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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 8  |  Issue : 2  |  Page : 82-89

A pilot clinical study of Mashadibasti in the management of Pakshaghata (Hemiplegia)


1 Department of Panchakarma, D. G. M. Ayurvedic Medical College and Hospital, Gadag, Karnataka, India
2 Department of Dravyaguna Vijnana, D. G. M. Ayurvedic Medical College and Hospital, Gadag, Karnataka, India

Date of Submission18-Sep-2021
Date of Decision13-Feb-2022
Date of Acceptance25-Feb-2022
Date of Web Publication29-Jun-2022

Correspondence Address:
Sonali Mukherjee
Department of Dravyaguna Vijnana, D. G. M. Ayurvedic Medical College and Hospital, Gadag, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AYUHOM.AYUHOM_45_21

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  Abstract 


Background: Pakshaghata is one of the diseases of central nervous system, considered as vatavyadhi in Ayurveda which occurs mainly due to vitiation of Vata. The disease pakshaghata can be compared with hemiplegia according to contemporary medicine. The mode of onset is sudden or gradual with the association of hypertension or diabetes mellitus. Loss of functions of limbs with or without the involvement of face is observed in this disease. It affects either left half or right half or both sides even. The present study is to evaluate the effect of Mashadi Basti in Pakshaghata. Objective: To evaluate the efficacy of Mashadi Basti, a type of medicated enema in management of Pakshaghata. Materials and Methods: A total of 15 patients were selected randomly. They were examined on the ground of Astavidha pariksha (eight-fold examination) from Ayurvedic point of view on the basis on specially prepared data research questionnaire. Selected subjects were administered with kala basti for 15 days and it was followed up of 30 days. Assessment was done through various variables like shareera akarmanyata or chestanivriti (Loss of motor activity), hasta pada ruja (pain in hand and leg), hasta pada sankocha (contraction in hand and leg), sira snayu shosha (rigidity), sandhibandha vimokshana (looseness of joints), and vak stambha (loss of speech), stroke specific– quality life scale, modified barthel index (MBI) and grip test. Results: The study showed that mashadi basti produced a significant (P < 0.05, P < 0.001) improvement in all the variables like shareera akarmanyata or chesta nivriti, hasta pada ruja, hasta pada sankocha, sira snayu shosha, sandhibandha vimokshana and vakstambha, stroke specific– quality life scale, MBI and grip test. Conclusion: Mashadi basti is found to be effective in Pakshaghata.

Keywords: Hemiplegia, Kala Basti, Mashadi Taila, Mashadi Yoga, Pakshaghata


How to cite this article:
Bera S, Mukherjee S. A pilot clinical study of Mashadibasti in the management of Pakshaghata (Hemiplegia). AYUHOM 2021;8:82-9

How to cite this URL:
Bera S, Mukherjee S. A pilot clinical study of Mashadibasti in the management of Pakshaghata (Hemiplegia). AYUHOM [serial online] 2021 [cited 2022 Aug 17];8:82-9. Available from: http://www.ayuhom.com/text.asp?2021/8/2/82/348860




  Introduction Top


Movement is a vital component of every living organism. According to Ayurveda, vata dosha is considered to conduct all type of motions. It is the chief dosha among the three humors.[1] Ayurvedic pathogenesis of the disease explains that aggravated vata enters the urdwa (upward), adhah (downward), and tiryakgata (lateral) dhamanis (veins) and destroys any one half of the body resulting Pakshaghata. It has been described that the affected part of the body becomes incapable of any work by this way and may become unconscious or person may even undergo for death.[2]

The terminology Pakshaghata literally means immobility of one side of the body where Paksha denotes the right or the left half of the body and aghata or paralysis denotes the impairment of Karmendriya (organ of action), Gyanendriya (sense organ), and Manas (mind). According to Charaka Samhita,[3] there is a derangement of Vata dosa due to involvement of certain etiologies followed by drying of the Snayu (nerves) and Sira (different types of vessels and lymphatics) in one half of the body manifested with specific features like inactivity of one half of the body, either right or left, associated with pain and loss of speech. Therefore, the treatment modalities that mitigate the deranged Vata dosa are the main principle of management for Pakshavadha. The description of Pakshaghata can be interpreted with hemiplegia. Hemiplegia can be defined as a condition characterized by paralysis in one half of the body due to lesions in motor area opposite side of the brain.[4] The basic pathogenesis lies behind development of hemiplegia is acute ischemic stroke of the brain involving any one or more pathogenic conditions like thrombolytic, inflammatory, and hemorrhagic changes of brain. Sudden or long-lasting hypertension is the major cause for such changes. There is acute occlusion of an intracranial vessel in blood flow to the region within a short interval of 4–10 min. Ischemia produces necrosis by starving neurons to glucose, which in turn results in failure of mitochondria to produce ATP. The Ca2/Na+ influx damaged due to decrease ATP level which lead to acceleration of proteolysis and breakdown of membrane and cytoskeletal structures of the motor area of the brain leading to cerebral cell death. Flaccidity of the movements of one half of the body opposite to the lesion of cellular death is the principal characteristic feature of the disease.[5] There are many therapeutic modules in Ayurveda for the management of Pakshaghata. Panchakarma – the five fundamental procedures of bio purification as mentioned in Ayurveda has been described vividly for the treatment of Pakshaghata.

Basti or a type of medicated enema is an essential therapeutic module described under Panchakarma. Basti is the most important treatment modality which extirpates the morbid vata. It is described in Ayurveda that vata dosha is in charge of controlling the other two doshas viz. pitta and kapha; dhatus (body tissues) and helps in expelling of Mala (waste products). Therefore, aggravated vatamay indirectly vitiate other doshas, dhatus and mala leading to exposition of numerousdiseases including Pakshaghata. Basti is considered as the best therapeutic measures for expelling the vitiated vatadosha. Basti is the only therapeutic procedure, which covers Rasayana (rejuvination) and Vajikarana (aphrodisiac) effects and removes Doshas from the three Roga-Margas or pathway for manifestation of diseases. Charaka aptly highlighted the glorified designation of Basti as – “Basti Vataharanam Shreshtha.”[6] Conclusively Basti, indeed, is considered as the half of the entire management of diseases.[7] Mainly basti is classified into two types asanuvasana basti (oil enema) and niruha basti (decoction enema).[8] Anuvasana basti is given after food and does not cause any complications. This can be applied daily basis. The peculiarity of this Basti is that it causes no adverse effects.[9] The Basti, which eliminates the vitiated dosha, and provides strength to the body, is known as Niruha Basti.[10]

Considering the vital importance of Pakshaghata for its clinical manifestations and underlying pathogenesis, the present pilot study was carried out with Masha Tailam under the process of Kala Basti in accordance with the classical description of Ayurvedic texts Charaduttam. The study was intended to restore the neurological actions along with musculoskeletal reinstatement. In the text Chakradatta, five types of Masha Tailam are described for the management of different vatavyadhis.[11] These are (i) swalpa masha tailam, (ii) masha tailam, (iii) dwitiya masha taila, (iv) tritiya masha taila, and (v) saptaprastha brihat masha taila. The second variety of Masha Taila is specifically indicated in pakshaghata.


  Materials and Methods Top


A total of 15 patients were selected through purposive or deliberate sampling technique for pilot study from D. G. M. Ayurvedic Medical College and Hospital, Gadag, Karnataka, India. They were examined on the basis of Astavidhapariksha or eight-fold examination procedure[12] from Ayurvedic point of view on the basis prepared data research questionnaire, relevant clinical examination,[13] stroke specific– quality life scale[14] and modified barthel index (MBI).[15]

Inclusion criteria

The patients of either sex between the ages of 30 and 70 years were selected for this study. Patients with classical sign and symptoms of Pakshaghata like shareera akarmanyata or chestanivriti (loss of motor activity), hasta pada ruja (pain in hand and leg), hasta pada sankocha (contraction in hand and leg), sira snayu shosha (rigidity), sandhi bandha vimokshana (looseness of joints), and vakstambha (loss of speech) were included.[16],[17] The diagnostic criteria for flaccid hemiplegia,[18] spastic hemiplegia,[19] and unspecified hemiplegia[20] of the disease were also included for the study.

Exclusion criteria

Patients with cerebral palsy[21] and other systemic involvement like diabetes mellitus, renal disorders, hepatic disorders, endocrine systemic disorders, and hypertensive heart disease; pregnant women; and unwilling to include in this clinical trial were excluded from the study.

Screening methods

All patients included in this study were examined on the basis of Astavidha pariksha from Ayurvedic point of view prepared on the basis of the data research questionnaire. Laboratory investigations like random blood sugar (mg/dl), prothrombin time, platelet count per cubic millimeter, and routine urine examination were done to all patients at baseline at Clinical Laboratory, D. G. M. Ayurvedic Medical College and Hospital, Gadag, Karnataka, India, to assess the health condition of patients for inclusion in the study. The prothrombin time and platelet were included in the current study to exclude any adverse effect of the Basti therapy, if any.

Preparation of drugs

Masha Taila [Table 1] was used for Anuvasana Basti [Figure 1] and Niruha Basti [Figure 2]. The principal ingredients of Masha Taila are seed of Masha pulses (Phaseolus mungo) and root of Bala (Sida cordifolia). Decoction (Kwatha) is primarily prepared by boiling with equal amount (768 g) of each of two ingredients and adding 16 times (12.288 L) of purified water and boiling till reduce to 1/4th of whole amount of water (3.072 L) and filtered. The decoction was then subjected to boil with Tila taila (Sesamum indicum oil) 768 ml and paste (Kalka) prepared with each 16 g of Masha (Phaseolus mungo), Atmagupta (Mucuna pruriens), Ativisha (Aconitum heterophyllum), Urubuk (Ricinus Communis), Rasna (Pluchea lanceolata), Satahva (Anethum sowa), and Saindhavalavana (rock salt) till the whole preparation stopped to produce boiling sound. The preparation procedure is followed as per the description of Ayurvedic classics.[22]
Figure 1: Anuvasana Basti

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Figure 2: Niruha Basti

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Table 1: Composition of Masha Taila

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Ingredients of Niruha Basti were makshik or honey (200 ml), saindhava lavana (15 g), masha taila (200 ml), and kalka as prepared with the same ingredients mentioned under the process of masha taila (30 g, 5 g each) and mashadi kwatha (400 ml). All the ingredients were mixed by triturating different ingredients one after another in order to makshik, saindhava lavana, sneha or oily substance (masha taila), kalka or paste (Masha, Atmagupta, Ativisha, Urubuk, Rasna, Satahva), kwatha or decoction (masha and bala) until it became a homogeneous mixture and heated over hot water to make it sukhoshna (luke warm).

All the ingredients of different drugs were collected from local market and were identified by the authentic person of the Department of Dravyaguna of this institution. The voucher specimen of the ingredients is preserved in the department.

Research design

The study was carried out in the manner of open-ended pre- and postrandomized clinical trial. A total of 15 patients were selected purposive or deliberate sampling technique for the pilot study [Figure 3].
Figure 3: Schematic presentation regarding selection of patients

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Intervention

All the patients were administered Kala Basti in this study. Kala Basti consists of 15 bastis given in a specific schedule, i.e., at the starting first Anuvasana Basti, then 5 alternate Anuvasana Basti and Niruha Basti each and last four sequence Anuvasana Basti was admnistered. The aequence is as follows Sl. 1: Anuvasana Basti, Sl. 2: Anuvasana Basti, Sl. 3. Niruha Basti, Sl. 4: Anuvasana Basti, Sl. 5: Niruha Basti, Sl. 6: Anuvasana Basti, Sl. 7: Niruha Basti, Sl. 8: Anuvasana Basti, Sl. 9: Niruha Basti, Sl. 10: Anuvasana Basti, Sl. 11: Niruha Basti and Sl. 12-15: Anuvasana Basti,[23] if administered alone without Anuvasana Basti, it may provoke Vata dosa due to its exclusive shodhana or purificatory property. Thus, to avoid this adverse effect of Niruha Basti, Anuvasana Bastis are assembled in between Niruha Basti sequences. Anuvasana basti was rendered with Masha taila with an amount of 100 ml empirically after taking some food preferably between 9 am and 10 am. Niruha Basti approximately with an amount of 800 ml was administered empirically in empty stomach preferably between 8 am and 8.30 am.

Duration of therapeutic intervention of Kala Basti was 15 days with follow-up after 30 days for next time. The nature and design of the study were explained to each patient and signed informed consent, prepared as per guideline of the WHO – Helsinki protocol was obtained. Accordingly, the study was approved by the Institutional Ethical Committee (DGM/ICE/13/PG/PK/05, D. G. M Ayurvedic Medical College, Gadag, dated April 13, 2012). All the data were collected from December 2013 to October 2014. During the study, patients were said to comply with the treatment protocol and report any unfavorable situation, if any, to the investigators at the earliest. Any manifestations either existing or new throughout the process of intervention that causes considerable distress were screened for possible adverse events.

Criteria for assessment

Assessment of signs and symptoms before and after the treatment was main criteria in the current research program. Clinical assessment is made for the severity of the disease and for the clinical improvement regarding the severity of individual symptoms assessment. The subjective parameters and objective parameters of baseline data to post therapy data is compared for assessment of the final results. The subjective parameters were (i) shareera akarmanyata, (ii) chesta nivriti, (iii) hasta pada Ruja, (iv) hasta pada sankocha, (v) sira snayu shosha, (vi) sandhibandha vimokshana, and (vii) vakstambha [Table 2]. The objective parameters were stroke-specific quality life scale [Table 3], MBI [Table 4] and [Table 5], and grip test.
Table 2: Demographic representation of different clinical features of patients suffering from hemiplegia vis-a-vis Pakshaghata

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Table 3: Effect of Mashadibasti on different parameter in related to Pakshaghata (hemiplegia)

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Table 4: Stroke specific quality of life scale scoring

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Table 5: Modified Barthel Index scoring

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Statistical methods

Statistical analysis was carried out using SPSS Version 23 (IBM). 0. Comparison of data at two time points was analyzed by paired t-test. Test was considered statistically significant at P < 0.005, P < 0.001.


  Results Top


Demographic values

A total 15 patients participated in the study. No patients reported any adverse effects. No patient dropped out during the study. The values of fundamental biochemical and hematological parameters like prothrombin time, platelet count, random blood sugar, and routine urine were found within normal range. It has been observed from the study that both the complaints like sharira akarmanyata or chesta nivritti and hasta pada ruja were found in all 15 patients (100%). The other symptoms like hasta pada sankocha were found in 10 patients (66.67%), sira snayu sankocha in 9 patients (60%), sandhibandha vimoksha in 8 patients (53.33%), and vak stambha in 5 patients (33.33%) [Table 6].
Table 6: Modified Barthel Index score and dependency level

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Parametric and nonparametric assessment

Assessment of the physical parameter as done by SSQOL scale showed that there was 48.03% relief, which is statistically significant (P < 0.001). Similarly, MBI showed there was 60.61% relief (P < 0.001). In grip test, there was 31.47% relief (P < 0.05). Regarding nonparametric clinical feature assessment, the akarmanyata showed that there was 58.60% relief (P < 0.05), ruja showed that there was 60.48% relief (P < 0.05), sankocha showed that there was 58.60% relief (P < 0.05), sosa showed that there was 58.60% relief (P < 0.05), sandhibandha vimoksha showed that there was 58.60% relief (P < 0.05), and vakstambha showed that there was 47.08% relief (P < 0.05) [Table 7]. However, in a nut shell, after the completion of the clinical trial, there was a significant improvement (P < 0.05-0.001) in all the variables like shareera akarmanyata, chesta nivriti, hasta pada ruja, hasta pada sankocha, sira snayu shosha, sandhibandha vimokshana, and vakstambha, stroke specific–quality life scale, MBI and grip test.
Table 7: Arbitrary scoring of subjective parameters

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  Discussion Top


Panchakarma is the modality of treatment that is significantly contributing in the worldwide embracement of Ayurveda. Basti, one of the modalities under five sections of Panchakarma, is unanimously praised by all ancient sages and designated as paramount treatment of Vata disorders. Vata disorders are very serious issue in chronic course and it is refractory in nature. These are the disorders, which inevitably cripple the sufferers, if not treated in the early stage and are designated as Mahagadas or serious outbreak of disease. In this regard, Basti therapy may prove a boon to the patients of Vata Vyadhi. If such pioneer treatment of Vata disorder is targeted mainly on the filthy disorders like Pakshaghata, it can mitigate the disease process to an extreme extent to recover the strength and vitality of the patient. Taking this objective as pectin mind, the present clinical study was designed to evaluate the efficacy of Mashadi Basti, which is well known for its confirmed ability to cure such diseases.

As per Parashara, Guda (rectum) is a vital organ of our body where most of the Siras (veins) are located. According to Ayurveda, Basti dravya (enematic medicines) are administered per rectum and it gets absorbed through the minute channels (Srotas) and thereafter reaches all over the body. This phenomenon has been compared with the process of transportation of water in remote parts of the plant after showering of water in the root. Conventionally, during administering of the Basti dravya, the patient should lie on the left lateral side as the Grahani (intestine) and the Guda (rectum) are present in the left part of the body so that the absorption is improved.[24],[25],[26] It is also mentioned in Ayurveda that when the Basti (medicated enema) enters through the anus, due to the strong potency of the medicine, it soaks the morbid doshas of the body, just as the sun sucks the moisture from the earth.[27] After the Basti is administered, its active principles merge with the apana vayu and samana vayu and thereafter it merges with all the other varieties of vayu's present in the body and control them through its action. It also controls the bhutas (body elements) similar to the nature of the active principle of the administered enema medicines. The transport of enematic medicine is by kedarikulya nyaya, which makes it spreads evenly all over the body by virtue of different vata. This quotation supports the theory of absorption of Basti active principles, i.e., phytochemical of the Basti as the action is dependent on gunas (qualities) which are the properties in dravya.[28]

In accordance with modern pharmacodynamics, there are four fundamental bases of delivery of drugs administered through the rectum as absorption mechanism, system biology mechanism, neural stimulation mechanism, and excretory mechanism.[29] Basti is the most adapted and highly effective multifaceted treatment in Ayurveda applied per rectum with specially prepared formulations. There are very limited scientific studies with Basti regarding its mode of absorption and action on the target organs. It is narrated that the rich supply of blood and lymph in the rectal mucosa helps absorb the unionized lipid soluble substances. It is also narrated that the delivery of drug through rectum depends on the amount of drugs to be administered which may be absorbed up to a certain level in systemic circulation. In the systemic circulation, there may be two major pathways as portal system and local system. The drug if delivered through the portal system from rectum may undergo for metabolism in liver followed by transportation in target tissues. On the other hand, in local transport system, drugs are absorbed through lower rectum and transported directly to the systemic circulation. It has been reported that about half of the concentration (50%) of a drug is absorbed from the rectum may be directly circulated in the system by means of bypassing of the liver.[30] In the rectal delivery of drug, the dosage form plays an important role. The liquid dosage formulation has faster absorption through the rectum, while there is retention and slow release of drugs formulated in fatty base.[31] In conventional process of preparation of Basti in Ayurveda, there are two types of formulations as aqueous in the name of Niruha Basti and lipid base in the name of Anuvasana Basti. Considering the above facts, it may be predicted that the first one may act by means of directly through portal circulation and the next one by means of systemic circulation where retention and slow absorption could be happened. The Anuvasana Basti is composed with lipids like hydrogenated vegetable oils which are categorized under lipophilic base whereas Niruha Basti can be categorized under hydrophilic base. Lipophilic bases are immiscible with body fluids and readily melt at body temperature to release the drug on the mucosal surface, whereas hydrophilic bases need to dissolve in the physiological fluids for drug release.[30] The absorption time of Niruha Basti is maximum of 48 min to get absorbed from the colon and rectum. This idea closely supports in another study where reactive oxygen species (ROS) was measured after 45 minutes of administration of Basti.[32] Retention time for Anuvasana Basti is relatively more so possibility of absorption increases. Anuvasana Basti helps in the formation of conjugate micelles by secreting bile from gallbladder after reaching in the rectum and colon. This conjugate micelle is absorbed through passive diffusion. In the treatment of Basti, a homogenous emulsion of honey, rock salt, oily substances, and decoction is a remarkable combination. It may be presumed that after whirling of drug mixture, the large and middle chain fatty acid may break into small chain fatty acids that can accelerate better absorption than a single drug. The fatty acids in molecular form may easily be transported in the system and thereby exerts its activity on a specific disease like Pakshghata or hemiplegia. In accordance with Ayurvedic principles of management, Vata dosa is the main pathological factor in Pakshaghata, which causes obstruction in the Pakvashaya (colon) followed by inhibition of absorption of nutrients. Evacuation of vitiated Vata by Niruha Vasti is the first line of management which promote nutritional supplementation to different parts of the body and Anuvasana Basti, possessing fatty components is responsible for reduction of Ruksha (rough) quality of Vata and promotes additional nutritional supplementation to the affected organs so that the inability of muscular activities may be eliminated. The molecular mechanism of Basti expresses its activity in a dual process for the patients suffering with Pakshaghata vis-à-vis hemiplegia.


  Conclusion Top


Basti is considered as one of the best treatment procedures in Ayurveda for the management of Pakshghata. The current research work entitled, “A pilot clinical study of mashadibasti in the management of pakshaghata (hemiplegia),” envisages that the criteria for the assessment of Basti therapy in Pakshaghata favor the improvement of clinical manifestations. Mashadibasti Kala Basti is the specific variety that significantly improves the signs and symptoms of Pakshaghata as well as the activities of daily livings, thereby making better the quality of life of the patients. However, detail molecular mechanism of Mashadibasti Kala Basti in favor of its role in mitigation of clinical features of Pakshghata is yet to be established.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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