| CTRI Number |
CTRI/2025/10/096387 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
in this study A clinical study to evaluate the effectiveness of Virechana followed by Vardhamana Pippali Rasayana in managing COPD (Tamaka Swasa) and assessing Desmosine levels as a lung degradation biomarker. |
|
Scientific Title of Study
|
A single-arm Clinical Study to evaluate the effectiveness of Virechana followed by Vardhamana Pippali Rasayana in the management of COPD (Tamaka swasa) along with assessing Desmosine level |
| 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 Km Jainab |
| Designation |
Pg Scholar |
| Affiliation |
All india institute of Ayurveda,Delhi |
| Address |
OPD 6, Department of Panchakarma, All India Institute of Ayurveda,
Gautampuri, Sarita Vihar Room no 725, Department of
Panchakarma, Academic Block, All India Institute of Ayurveda, Delhi
New Delhi
South
DELHI
110076
India |
| Phone |
8006909057 |
| Fax |
|
| Email |
zainabsalmanizry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anandaraman PV |
| Designation |
Head of Department, Panchakarma |
| Affiliation |
All india institute of Ayurveda,Delhi |
| Address |
7TH FLOOR , Department of Panchakarma, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South
DELHI
110076
India |
| Phone |
9495130595 |
| Fax |
|
| Email |
dr.ananthramsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPraveen kumar KS |
| Designation |
Assistant professor,MD,Phd ,Department of Panchakarma |
| Affiliation |
All india institute of Ayurveda,Delhi |
| Address |
7TH FLOOR , Department of Panchakarma, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South
DELHI
110076
India |
| Phone |
9447506528 |
| Fax |
|
| Email |
dr.praveenkumarks@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Gautampuri Mathura road sarita vihar new delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda, Delhi |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Delhi -
110076
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrKm Jainab |
All India Institute of Ayurveda |
room 703, 7th Floor, department of panchakarma, All India Institute of Ayurveda Gautampura Sarita Vihar New Delhi 110076
South
DELHI |
08006909057
zainabsalmanizry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J449||Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Ashtanga Hridaya, Procedure details: Virechan is an ayurvedic panchkarma procedure of medicated purgation. It is the procedure of body detoxification, By which ‘Pitta dosha’ is eliminated from body.)
(1) Medicine Name: Trivritta Avaleha, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 70(g), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vardhman pippali rasayana, Reference: charak chikitsa 1-3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 0.69(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 19 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 25 and 60 years.
Diagnosed with Tamaka Swasa based on Clinical signs and symptoms like
Swasakrichata,kasa,urashoola,ghurghurkam shabada,peenasa,anidra, etc.
Classified with mild to moderate COPD according to GOLD criteria.
FEV1/FVC ratio is less than 0.70 postbronchodilator, and FEV1 ranges from 50% to 80% of the
predicted value.
Willing and able to undergo Virechana Karma and Vardhamana Pippali Rasayana.
Provided a written informed consent.
asthma
|
|
| ExclusionCriteria |
| Details |
Severe or very severe COPD (FEV1 below 50% of predicted) or an acute exacerbation in the last 4 weeks.
FEV1/FVC ratio exceeding 0.70 (indicating a non-obstructive pattern)..
Severe respiratory distress requiring emergency care, known case of Lung cancer, bronchiectasis,
interstitial lung disease, Congenital heart disease, uncontrolled Diabetes mellitus, pneumonia, lung
fibrosis, HTN, pneumothorax, and tuberculosis.
Women who are pregnant or breastfeeding Individuals who are unfit for Virechana karma and Vardhamana pippali rasayana
Patient taking steroid therapy (systemic or inhaled corticosteroid)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical presentation along with lung function tests (FEV1/FVC, FEV1%, PEFR) |
Baseline, AT, AF |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in urine desmosine level
Improvement in quality of life (SF-36)
Changes in CAT Questionnaire score, Mmrc Dyspnea scale, and BODE Index
|
Urine desmosine-baseline, AT
Subjective parameters: baseline, AT, AF |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This dissertation proposes a clinical study to see how well an Ayurvedic treatment works for a lung disease called COPD, which is known in Ayurveda as Tamaka Swasa. The main goal is to check if a specific treatment, which involves Virechana followed by Vardhamana Pippali Rasayana, improves a patient’s symptoms and lung function. A secondary goal is to see if it reduces a biomarker called Desmosine, which shows lung damage. The study also aims to see if the treatment improves the patient’s quality of life and other health scores. The study is being done because COPD is a big problem worldwide, and regular medicines often just help with symptoms without stopping the disease from getting worse. This research hopes to scientifically prove that traditional Ayurvedic methods can help protect the lungs and keep the condition from progressing. How the Study Will Be DoneThe study is an exploratory, single-arm clinical trial and will involve 36 people. The treatment will last for 92 days. Who can participate: People between 25 and 60 years old. People diagnosed with Tamaka Swasa. People with mild to moderate COPD. People who are willing to go through the treatment. Who cannot participate: People with severe or very severe COPD. Anyone who has had a recent flare-up of the disease. People with other serious health conditions like lung cancer or uncontrolled diabetes. Pregnant or breastfeeding women. People who are currently taking steroids. |