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CTRI Number  CTRI/2023/09/057211 [Registered on: 01/09/2023] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the efficacy of Vamana with Madhanaphala Dadhiyoga and Madhanaphala Yoga of Vamana in Tamaka Swasa vis-a-vis to Bronchial Asthma 
Scientific Title of Study   A randomised open labelled comparative clinical study to evaluate the efficacy of Madhanaphala Dadhiyoga and Madhanaphala Yoga of Vamana in Tamaka Swasa vis-a-vis Bronchial Asthma. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niti Yogendrbhai Laheru 
Designation  MD Scholar 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 
Address  2nd FLOOR, DEPT.OF PANCHAKARMA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, 21 ST KANAKAPURA ROAD, UDAYAPURA P.O., BENGALURU-560082.

Bangalore
KARNATAKA
560082
India 
Phone  7359012062  
Fax    
Email  drnitilaheru9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prajwal Narayan 
Designation  Professor  
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 
Address  2nd FLOOR, DEPT OF PANCHAKARMA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, 21 ST KANAKAPURA ROAD, UDAYAPURA P.O., BENGALURU-560082.

Bangalore
KARNATAKA
560082
India 
Phone  8951072206  
Fax    
Email  prajwal.ayurveda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prajwal Narayan 
Designation  Professor  
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL 
Address  2nd FLOOR, DEPT OF PANCHAKARMA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, 21 ST KANAKAPURA ROAD, UDAYAPURA P.O., BENGALURU-560082.

Bangalore
KARNATAKA
560082
India 
Phone  8951072206  
Fax    
Email  prajwal.ayurveda@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital,21ST K.M., Kanakapura road, Udayapura P.O.,Bengaluru- 560082 
 
Primary Sponsor  
Name  Dr. Niti Y. Laheru 
Address  2nd FLOOR, DEPARTMENT OF PANCHAKARMA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, 21 ST KANAKAPURA ROAD, UDAYAPURA P.O., BENGALURU-560082. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niti Y Laheru  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH  OPD NO. 8 DEPARTMENT OF PANCHAKARMA, SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, 21 ST KANAKAPURA ROAD, UDAYAPURA P.O., BENGALURU-560082
Bangalore
KARNATAKA 
7359012062

drnitilaheru9@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, (3) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charaka Samhita Chikitsasthana Hikka Swasa adhyaya, Procedure details: PURVA KARMA DEEPANA PACHANA Chitrakadi vati Will be given with lukewarm water twice daily before food until Nirama Lakshanas are achieved. SNEHA PANA Kantakari ghrita will be given in the Arohana krama, till the Samyak Snigdha Lakshanas are observed. VISHRAMA KALA Sarvanga Abhyanga will be done with Saindhavadi Taila for 45 minutes followed by Bashpa Sweda. Kapha Utkleshakara Ahara like sweet pongal, curd rice, dahi vada, milk, prepared sweets, etc. intake will be advised. ))
(1) Medicine Name: Madhanaphala Ypga, Reference: Charaka Samhita Chikitsasthana Hikka Swasa adhyaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 7(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Sushruta Samhita Chikitsasthana Vamanadravya Vikalpavijnananiya adhyaya, Procedure details: PURVA KARMA- DEEPANA PACHANA- Chitrakadi vati Will be given with lukewarm water twice daily before food until Nirama Lakshanas are achieved. SNEHA PANA- Kantakari ghrita will be given in the Arohana krama, till the Samyak Snigdha Lakshanas are observed. VISHRAMA KALA Sarvanga Abhyanga will be done with Saindhavadi Taila for 45 minutes followed by Bashpa Sweda. Kapha Utkleshakara Ahara like sweet pongal, curd rice, dahi vada, milk, prepared sweets, etc. intake will be advised. ) (1) Medici)
(1) Medicine Name: Madanaphala Dadhi yoga, Reference: Sushruta Samhita Chikitsasthana Vamanadravya Vikalpavijnananiya adhyaya, Route: Oral, Dosage Form: Dravaka, Dose: 200(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects with classical signs and symptoms of Tamaka Swasa.
Subjects who are willing to give a written consent for the treatment.
Subjects fit for Vamana. 
 
ExclusionCriteria 
Details  Subjects below 21 years and above 50 years of age.

Subjects unfit for Vamana.

Subjects who are having systemic disorders, which interfere with the treatment.

Subjects who are on medication with Corticosteroids, anti-depressants and any other drug that may have an influence on the outcome of the study.

Pregnant and lactating women.

Severe attack of Tamaka Swasa having the peak flow expiratory rate. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To analyse the effectiveness of Madhanaphala Dadhi yoga over Madhanaphala yoga in treating Tamaka Swasa/ Bronchial Asthma. Which can be further be used in clinical practice
points that will be assessed as primary outcome :
Morning worsening of asthma symptoms
Swasa kshta (Shortness of breath)
Shayana Swasapidita (breathlessness increase in lyin position)
Use of bronchodilator  
0th day - Before commencement of treatment.
During treatment - Maximum days of treatment i.e.on 16th day i.e.day of Vamana.
Follow up - Maximum on 23rd day (7 days after Vamana)
 
 
Secondary Outcome  
Outcome  TimePoints 
Establishment of Madhanaphala Dadhi Yoga as one of the Aushadha Upakrama of Tamaka Swasa, which can further be used in Ayurvedic clinic practice

points that will be assessed as secondary outcomes.
Night awakening
Kapha vimokshante labhate sukham (comfort after sputum expulsion)
Limitation of activity
Swasa muhu cha eva dhayate (Wheezing) 
0th day - Before commencement of treatment.
During treatment - Maximum days of treatment i.e.on 16th day i.e.day of Vamana.
Follow up - Maximum on 23rd day (7 days after Vamana)
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

A randomised open labelled comparative clinical study to evaluate the efficacy of Vamana with Madhanaphala Dadhiyoga and Madhanaphala Yoga of Vamana in Tamaka Swasa vis-a-vis to Bronchial Asthma.

  

                                                                                                                                                                                                                                                                         

P G Scholar : Dr. Niti Laheru                                                                                        Guide : Prof. Prajwal Narayan                                                                                                                                                                              

 

Introduction: Tamaka Swasa, one among the 5 types of Swasa Roga. it is analogous with Bronchial Asthma having cardinal features of episodic attacks of breathlessness, tightness in the chest, wheezing, coughing and increased mucus production. Asthma attacks can begin suddenly and range from mild to life threatening as it may lead to swelling in the airways which prevents oxygen to reach the lungs and hence urgent medical attention becomes necessary. According to WHO report, 100-150 million of global populations are suffering from Bronchial Asthma, out of which 1/10th are Indians and the prevalence of Asthma is increasing everywhere Current estimates suggest that 339 million people worldwide suffer from Asthma and an additional 100 million may be diagnosed with Asthma by 2025. Also by the year 2020 Asthma along with Chronic Obstructive Pulmonary Disease will become the third leading cause of death. Acharya Charaka has mentioned that Tamaka Swasa is Kapha Vataja - Vikara and site of origin is Pittasthana. Other Acharyas have mentioned it as Kapha Pradhana Vyadhi. A critical review of relevant literature about, Tamaka Swasa will be done on the basis of available Ayurvedic text books, previous research works, Journals etc. Clinical study will be carried out in the form of detailed history and assessment of the treatment by preparing a special performance. 

Material and Methods: Total 30 patients of Tamaka Swasa will be enrolled in this study. Which will be divided in two groups. Group A (Trail group) will be treated with Madhanaphala Dadhiyoga. Group B will be treated with Madhanaphala yoga as a standard control. The raw  drugs and prepared product will be subjected to the standard analytical study protocol followed in the the institute for authencity of raw drugs and finished product. The duration of treatment will be of 16 days followed by the seven days follow-up. The treatment will also include deatails of Pathya- Apathya (Do’s and Don’ts of diet and regime). Subjective criteria will be used in current study for assessment purpose. 

Results and Discussion :The assessment of the treatment will be done based on clinical subsidence in the symptoms in terms of percentage and result will be categorized into Complete remission, markedly improved, moderately improved, mild improved and unchanged. Results will also be statistically analysed for the purpose of comparison of results of both the groups.

 


 
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