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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (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 | 2 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (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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