|Year : 2021 | Volume
| Issue : 1 | Page : 16-24
A randomized comparative clinical study on Tamaka Shwasa (bronchial asthma) with Vamana and Virechana along with Shamana therapy
G Babu1, Hari Mohan Lal Meena2, Ram Kishor Joshi2, Anu Bhatnagar3, Rashmi Mutha2, Bharat Chhaganbhai Padhar2, Shankar Gautam2
1 Central Ayurveda Research Institute, Jhansi, Uttar Pradesh, India
2 Department of Kayachikitsa, National Institute of Ayurveda, Jaipur, Rajasthan, India
3 Central Ayurveda Research Institute, New Delhi, India
|Date of Submission||04-Aug-2021|
|Date of Decision||20-Sep-2021|
|Date of Acceptance||13-Oct-2021|
|Date of Web Publication||26-Nov-2021|
Dr. Shankar Gautam
Department of Kayachikitsa, National Institute of Ayurveda, Jaipur - 302 002, Rajasthan
Source of Support: None, Conflict of Interest: None
Introduction: Tamaka Shwasa (TS) is mentioned as one of the varieties among five types of Shwasa Roga as a “Swatantra Vyadhi” and has its own etiology, pathology, and management which resembles with bronchial asthma. Asthma affects about 6% of children and 2% of adults in India's 1.31 billion population. In TS, two treatment modalities Shodhana and Shamana have been explained. Hence, an attempt had been made to clinically compare the result of Vamana Karma and Virechana Karma along with the same Shamana drugs, i.e. Shrungyadi Churna with Guduchyadi Kashaya. Methodology: This study was an open comparative clinical trial with sample size 100 patients (50 in each group) for duration of 60 days. The intervention for Group I was Vamana Karma, whereas for Group II was Virechana Karma, followed by Shamana Chikitsa in both groups. Required hematological, radiological and routine examinations, pulmonary function tests, Asthma Control Questionnaire, St. George's Respiratory Questionnaire, and other parameters were assessed for the clinical evaluation. Results and Discussion: In both group, the parameters such as Asthma Control Questionnaire, SGRQ-C score, Peak expiratory flow rate (PEFR), Forced expiratory volume in one second (FEV1), Hemoglobin, Total leukocyte count, Eosinophils, Erythrocyte sedimentation rate and Absolute eosinophil count have shown significant (P < 0.0001) improvement. In comparison to Group I (relief percentage range from 46% to 92.68%), Group II treatment has shown better results in the relief (60%–90%) of all the clinical parameters of Tamaka Swasa (Bronchial asthma). No significant adverse effects have been noted throughout the study. Conclusion: Both Vamana and Virechana along with administration of Shamana drugs have statistically highly significant effect in TS (Bronchial asthma). However, the Virechana shows better relief in clinical symptoms as compared to Vamana.
Keywords: Asthma control questionnaire, Bronchial asthma, Tamaka Shwasa, Vamana, Virechana
|How to cite this article:|
Babu G, Lal Meena HM, Joshi RK, Bhatnagar A, Mutha R, Padhar BC, Gautam S. A randomized comparative clinical study on Tamaka Shwasa (bronchial asthma) with Vamana and Virechana along with Shamana therapy. AYUHOM 2021;8:16-24
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Babu G, Lal Meena HM, Joshi RK, Bhatnagar A, Mutha R, Padhar BC, Gautam S. A randomized comparative clinical study on Tamaka Shwasa (bronchial asthma) with Vamana and Virechana along with Shamana therapy. AYUHOM [serial online] 2021 [cited 2022 Jan 22];8:16-24. Available from: http://www.ayuhom.com/text.asp?2021/8/1/16/331322
| Introduction|| |
Tamaka Shwasa (TS) is mentioned as one of the varieties among five types of Shwasa Roga. TS is a “Swatantra Vyadhi” (independent disease) and has its own etiology, pathology, and management. It is mentioned as Yapya Vyadhi, i.e. incurable but manageable disease. In this condition, Kapha which is the predominant dosha causes obstruction in Pranavaha Srotas (channels of respiration), thereby disturbing the movement of Vata. Consequently, Vata is aggravated and its Pratiloma gati (reverse spreading) takes place, which results in Shwasa Kashtata (dyspnea). Pranavaha srotas, Annavaha srotas (digestive tract), and Udakavaha srotas (channels for fluid circulation) are also involved in TS, a condition, which in modern parlance is known as Bronchial asthma.
Asthma affects about 6% of children and 2% of adults in India's 1.31 billion population. Worldwide, an estimated 300 million individuals suffer from asthma, with 250,000 deaths annually due to the disease. It is estimated that the number of people with asthma will increase by more than 100 million by 2025.
In TS, two treatment modalities have been explained. One is Shodhana (bio-cleansing therapy) and another is Shamana (pacifying therapy), Shodhana and Shamana for the persons who are strong and Shamana for the persons who are weak. Administration of Snehana (unctuousness), Swedana (sudation therapy), Vamana (therapeutic emesis), Virechana (therapeutic purgation), Shamana and Brumhana (nourishing therapy) line of treatment forms the complete treatment of TS as explained in Ayurvedic classics. In Shodhana, although both Vamana Karma and Virechana Karma are advised for the management of TS, there are very few clinical studies comparing the efficacy of Vamana versus Virechana. Some clinical studies showed that the Virechana has synergistic effect in curing TS, and thus, the concept of Ayurveda classics has been validated.,, Furthermore, there are only limited clinical studies regarding the evaluation of the efficacy of Vamana therapy. An attempt had been made to clinically compare the result of Vamana Karma and Virechana Karma along with the same Shamana drugs, i.e. Shrungyadi Churna [Table 1] with Guduchyadi Kashaya, in the patients of TS (Bronchial asthma). This study revalidates the prioritization of Virechana Karma among Shodhana Karma and also validates that Vamana can also play a significant role in treating TS.
- To evaluate and compare the efficacy of Vamana and Virechana Karmas along with Shamana Chikitsa by Shrungyadi Churna and Guduchyadi Kwath orally in TS (Bronchial asthma).
| Methodology|| |
- Type of study: Open randomized comparative single centric clinical trial
- Sample Size: 100 patients (50 in each group)
- Sampling method: Simple Random Sampling Method (Lottery Method).
This study is carried out as per international conference of harmonization-good clinical practices guidelines (ICH-GCP) or as per the Declaration of Helsinki guidelines. An informed written consent was taken from each patient willing to participate before the commencement of the trial. The patients were free to withdraw their name from the study at any time without giving any reason. The preapproval from concerned bodies was taken before this research work.
- Group I: 50 patients selected for Vamana Karma, afterward Shrungyadi Churna has been given as Shamana Chikitsa
- Group II: 50 patients administered for Virechana Karma, afterward Shrungyadi Churna has been given as Shamana Chikitsa.
The treatment modalities used in this clinical study are Vamana and Virechana Karmas, which include Deepan-pachan (digestion and metabolism enhancing) with Panchakola Churna, Snehapana (internal oleation) with Dashamooladi Ghritam, Abhyanga (therapeutic massage) and Swedana with Murchita Tila Taila (Sesame Oil), and Nadi-Sweda (sudation using pipe like instrument), respectively. Vamana with Madanaphala Yoga and Virechana with Trivrit Churna followed by Samsarjana Krama (posttherapy dietetic regimen for revival) means provided the Manda (rice water), Peya (thin gruel of rice), Vilepi (thick gruel of rice), and Yavagu (gruel) for 7 days, afterward Shrungyadi Churna with Guduchyadi Kwatha has been given as Shamana Chikitsa. After 1 month of treatment, patients of both groups of Shamana Chikitsa were followed up for another 1 month with the interval of 1 week.
- Posology of the drug: Shrungyadi Churna – 5 g b.d with honey
- Anupana of the drug: Guduchyadi Kwatha – 30 ml.
Study duration: 60 days
The present study has been carried out from September 2013 to June 2015 in the National Ayurveda Research Institute for Vector-Borne Diseases (NARIVBD), Vijayawada, Andhra Pradesh, India.
Selection of patients
For the present study, 100 patients fulfilling the clinical criteria for the diagnosis of TS (Bronchial Asthma) were randomly selected irrespective of their age, sex, religion, etc., from the I.P.D. and O.P.D. of NARIVBD, Vijayawada.
Criteria for inclusion
- Typical features of TS (Bronchial asthma) such as difficulty in breathing, episodic attacks of dyspnea, wheezing sounds, difficult expectoration, relief of dyspnea in erect position or after expectoration, and decreased pulmonary function
- The patients suitable for Vamana and Virechana Karma
- Age between 20 and 60 years of either sex
- Duration of the disease up to 5 years.
Criteria for exclusion
- Cardiac asthma or history of acute attack which needed treatment with lifesaving drugs, oxygen, steroids, etc.,
- Patients having lung pathology of other nature such as tuberculosis, pleurisy, hydrothorax, pneumothorax, pyothorax, malignancy, and tropical pulmonary eosinophilia
- Patients with a history of diabetes mellitus, hypertension, severe systemic disease, liver or renal disease in the recent past
- PEFR <35%.
Criteria for withdrawal
During the course of the trial treatment, if any serious condition or any serious adverse effect which requires urgent treatment or if patient himself wants to withdraw from the study, such subject may be withdrawn from the trial.
Plan of study
Shodhana therapy is divided into Purva Karma (preparatory procedures), Pradhana Karma (main therapeutic procedures), and Paschat Karma (posttherapy procedures) [Table 2] and [Figure 1].
For both the groups, Purva Karma is the same, i.e.,
- Deepana-pachana: Panchakola Churna 5 g, 2 times a day 1 h before food with Luke warm water
- Snehapana: For Snehapana, Dashamuladi Ghrita was selected. After attaining appropriate Niramata, Snehapana was started with Hraseeyasi Matra, i.e. 35 ml and Arohana Snehapana till Samyak Snigdha Lakshanas (optimal oleation symptoms) are seen. It was given for 3–7 days
- Vishrama kala (Abhyanga and Sweda): The patients were administered Abhyanga and Nadisweda. For Abhyanga, Murchita Tila Taila was used. Vishrama Kala for Vamana is 1 day and for Virechana is 3 days.
- Vamana Karma: For Group I patients, after attaining Samyak Snigdha Lakshanas, 1-day rest was given and also taken Kapha Vardhaka Ahara (milk, sweets, cheese, curd, banana, rice pudding) in dinner. Next day, Vamana Yoga was given after assessing the status of the patient's Koshtha (nature of bowel), Bala (strength/physical endurance), etc., The medicine used was Madanaphala Yoga (Madanaphala Churna, Pippali Churna, Saindhava lavana in the dose of 4:2:1 ratio ranging from 7 to 14 g and honey in required quantity) along with sufficient quantity of Yashtimadhu Phanta and Milk
- Virechana Karma: For Group II patients, after attaining Samyak Snigdha Lakshanas, 3 days' rest was given and also taken Pitta Vardhaka Ahara Vihara (such as Ghrita, use of hot and sour food, use of spices such as Sunthi, Marich, Ajwain in food, Morning Sunbath). Next day, Virechana Yoga was given after assessing the status of patient's Koshta, Bala, etc., The medicine used was Trivrit Churna along with lukewarm water.
- Samsarjana Krama: In both the groups, Samsarjana Krama was performed depending upon the Shuddhi.
Shaman Chikitsa for both groups: After administration of Vamana Karma and Virechana Karma, Shamana drugs were given. For this purpose, Shrungyadi Churna in the dose of 5 g daily with Guduchyadi Kwath orally was given.
Follow-up was done for 30 days. During this period, Shrungyadi Churna along with Guduchyadi Kwatha orally was given. During and after the treatment, patients were advised for taking the diet and performing the activities which are beneficial for them, i.e. Hita Ahara and Vihara such as:
Do's (Pathya): Godhuma (wheat), Old rice, Mudga (green gram), Kulattha (Horse gram), Yava (barley), Patola (snake gourd), Use of Garlic, Turmeric, Ginger, Black pepper, Luke warm water, Goat milk, Honey, Respiratory exercise, Pranayama, Yoga.
Don'ts (Apathya): Heavy, cold diet, Masha (black gram), deep fried items, mustard leaves, fish exposure to cold and humid atmosphere, sweets, chilled water, stored food items, curd, suppression of natural urges, excessive physical exertion, exposure to smoke, dust and fumes, pollutants, and pollens.
- Hematological investigations such as Hb, TLC, Differential Leukocyte Count (DLC) and ESR
- Routine and microscopic examination of urine
- Sputum: Acid-fast bacillus (if necessary)
- Stool: Routine and microscopic examination
- Radiology: Chest X-ray – posteroanterior view
- Pulmonary function tests: Peak flow meter and spirometry.
Primary outcomes – Changes in FEV1 and PEFR.
- Relief in subjective parameters
- Changes in ACQ score and SGRQ.
Routine examination and assessment
A detailed clinical history and physical examination of each trial subject were recorded as per the case record form. The clinical, pathological, and biochemical investigations were done as recommended in the pro forma at 0th day, 30th day, and 60th day.
Criteria for assessment of the result
A detailed history and physical examination were done on the basis of the standard pro forma, which included both Ayurvedic and modern methods of examination. The changes in the subjective [Table 3] and objective parameters along with laboratory investigations before and after the treatment were considered for assessment of the efficacy and safety of the drug.
Other assessment tools:
- Asthma control questionnaire
- St. George's respiratory questionnaire
- Determination of Prakriti: Parameters for Determination of Deha Prakriti
- Determination of Manasa Prakriti:
- Assessment of Sara
- Assessment of Samhanana
- Assessment of Satmya
- Assessment of Sattva
- Assessment of Ahara Shakti
- Assessment of Vyayama Shakti
GraphPad Prism version 6 was used for statistical analysis.
The results obtained on subjective and objective variables were calculated and statistically analyzed. To check the significance of subjective variables, “Wilcoxon matched-pairs signed-rank test was used for intragroup comparison and the Mann–Whitney test was used for intergroup comparison.” While for objective variables, “Paired t-test was used for intragroup comparison and the unpaired t-test was used for intergroup comparison.”
| Observation and Results|| |
The Shrungyadi Churna was studied for organoleptic characters and physicochemical properties. Its pH is 5.35 with little acidic in nature. Loss on drying is 9.20%, total ash is 5.06%, acid insoluble ash is 0.60%, water-soluble extractives are 21.12%, and alcohol soluble extractives are 15.58%. The analytical study of Shrungyadi Churna (limit tests for heavy metals) showed that heavy metal toxicity of lead and arsenic are within normal limits.
In the total distribution of the age in both groups, the more propounded age group was 51–60 years and sex-wise incidence of females is higher (64%) than males. In this study, 30% of the population has fieldwork with physical labor as their occupation that has more contact to allergens followed by the housewives who have moderate contact with the allergens. Forty-four percent of the population including both groups comes from the urban area. Such population is more prone to allergens due to pollution and frequent infections due to congested environment. Most of the population in this study have no addiction. However, 24% of the people are smokers, 16% are chewing tobacco, and 12% are addict to alcohol. Smoking provokes Bronchial asthma. On the evaluation of Sharira Prakriti, Vata-Kapha individuals are more prone to the disease being 40% and are followed by Pitta-Kapha individuals with 20%. There is no direct relation between body weight and incidence of Bronchial asthma but being 19% of individuals fall above 30 of body mass index (BMI). Twenty percent individuals fall under 25–29.9 BMI; we may conclude that the individuals having overweight have more risk of developing Bronchial asthma.
In Group I, a maximum of 48% patients experienced Madhyama Shuddhi of Vamana, 44% patients experienced Pravara Shuddhi while 8% showed Avara Shuddhi. In Group II, a maximum of 50% patients experienced Madhyama Shuddhi of Virechana, 32% patients experienced Avara Shuddhi while 18% got Pravara Shuddhi.
In both group, except for skin allergy, there was significant result (P < 0.0001) observed. Whereas for skin allergy, there was a significant result with “P” value as P = 0.0054 for Group I and P = 0.0009 for Group II. The overall relief in subjective parameters of Group I is found to be good [Graph 1], while maximum is observed in the tightness of chest (92.68%) and minimum in breathlessness (46%). Based on the observations made in the study in Group II, overall relief in subjective parameters is found to be extremely good [Graph 2], while maximum is observed in the tightness of chest (90%) and minimum in paroxysm of breathlessness (60%).
In both group, the parameters such as Asthma Control Questionnaire, SGRQ-C score, PEFR, FEV1, Hb%, TLC, eosinophils, ESR, and AEC have shown extremely significant (P < 0.0001) statistical values [Table 4]. The value of neutrophils shows statistically very significant (P < 0.01), whereas the values of lymphocytes and monocytes are not statistically significant (P > 0.05).
Comparison between Groups I and II [Table 4] and [Graph 2] as follows:
Group II has shown greater statistical significance (P < 0.0001 except for skin allergy, i.e. P = 0.0009), attributing to Virechana, Group I has also shown better results (P < 0.0001 except for skin allergy, i.e. P = 0.0054), Group II proved to be effective when compared to Group I in relieving the symptoms such as breathlessness, paroxysm of breathlessness, wheezing, expectoration of sputum, tightness in the chest, worsening of breathlessness in the night and awakening in the night, whereas in case of cough, Group I was found to be beneficial when compared to Group II. Relief of skin allergy showed no difference between both the groups as the mean difference values are the same.
Objective parameters such as Asthma Control Questionnaire Score, SGRQ score, and FEV1 indicated more significant (P < 0.0001) in both groups [Table 4]. However, clinically relief evaluation shows more improvement in Group II when compared to Group I. In contrast, PEFR showed more improvement in Group I when compared to Group II [Graph 2].
| Discussion|| |
TS, if not properly treated, will kill the patients like the fire burns the dried bush. Even though TS is a Yapya Vyadhi, it becomes Sadhya if the patient possesses good strength and is of recent origin. There is a feeling among the common masses that Shwasa roga will go only when Shwasa (Prana) goes away, i.e. death. Shwasa is considered Krichra Sadhya or difficult to cure.
By Snigdhatva of Sneha and Swinnatva of Sweda to the body, the Vilayana of Kapha might have been taken place in the bronchioles. Ushna, Tikshna, Sukshma, Vyavai, Vikasi Gunas, and Urdhwagata Swabhava take place; henceforth by virtue of Vamana, Kapha is expelled out of the bronchioles through mouth. In case of Virechana, Ushna, Tikshana, Sukshma, Vyavai, Vikasi Gunas, and Adhogata Swabhava, Kapha in Urahsthana comes to Amashaya and expelled out by Virechana through anus. Virechana containing group has better results than the next. This finding resembles with the statement of the Acharyas as Udbhava Sthana of TS is Pitta Sthana and the best suited Shodhana for Pittasthana is Virechana.
Dashamoola is indicated in Vata predominant Tridoshaja disorders. Dasmooladi Ghrita is used for Vata-Kapha disorders. Tila Taila has Sukshma Guna, Ushna Veerya Vata-Kapha Nashaka properties and is used for snehana. Most of the drugs used in the Shrungyadi Churna with Guduchyadi Kwatha have Tikta, Katu, Kashaya Rasa, Laghu, Ruksha, Tikshna Gunas, Ushna Virya and Vata-Kaphahara properties which are Hetu Viparita, Vyadhi Viparita and Hetu-Vyadhi Viparita Upashayas in TS. Hence, the drugs aptly suit for this disease. The ingredients of Shrungyadi Churna such as Karkatashringi, Shunthi, Pippali, Musta, Pushkaramula, Maricha, and Guduchi predominantly have anti-inflammatory activity which might have reduced inflammation in the bronchioles. Karkatashrungi, by virtue of its expectorant action expelled the blocked mucous in the bronchioles, Guduchi and Pippali might have caused immune-modulatory effect; Vasa might have caused bronchodilator effect. The synergistic action of all the drugs might have pacified Bronchial asthma. However, we cannot conclude the action of above drugs by this study; further studies with larger sample are required to find the action of above drugs.
In comparison to Group I, Group II treatment has shown better results in the relief of all the clinical parameters of Tamaka Swasa (Bronchial asthma). No significant adverse effects have been noted throughout the study. The improvement observed in clinical parameters in Group II can be attributed to the fact that Virechana is the prime remedy to pacify TS, as “Vata Shleshma Kaphairyuktam Tamaketu Virechanam” has been said by Acharya Charaka wisely. Virechana is the prime modality in treating Pitta Sthanagata diseases. Likewise, TS which is also a “Pitta Sthana Udbhava Vyadhi” has been pacified to its fullest by Virechana Karma.
Even though Group II has shown greater statistical significance (P < 0001 except for skin allergy, i.e. P < 0.0009, relief percentage ranges between 46% and 92.68%), attributing to Virechana, Group I has also shown better results (P < 0001 except for skin allergy, i.e. P < 0.0054; relief percentage ranges between 46% and 92.68%), owing to the Kaphahara Karma of Vamana. By virtue of anti-inflammatory, bronchodilator, and immuno-modulatory properties of the ingredients of Shrungyadi Churna being taken as a Shamana Aushadhi, the role of it in pacifying TS cannot be ruled out. However, further studies with larger samples and better control will be effective in assessing the prudence of the drugs.
| Conclusion|| |
Both Vamana and Virechana along with administration of Shamana drugs have statistically highly significant effect in TS (Bronchial asthma). However, the Virechana shows better relief in clinical symptoms as compared to Vamana.
- There is a need for further specific research for each Vamana and Virechana with consideration of Dosha, Kala, Desha, Prakriti, etc., Ayurvedic parameters specified in Ayurveda classical texts
- There is a need for further molecular studies for evaluating the efficacy of drugs used in this study
- There is a need for multicentered studies on larger groups with controls.
Financial support and sponsorship
This study was financially supported by National Institute of Ayurveda (for research work).
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]