| CTRI Number |
CTRI/2026/01/100961 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| 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
|
This is a study to know how Vyaghryadi kashayam and bharangi-shunthi churna works in respiratory diseases. |
|
Scientific Title of Study
|
A Randomized Controlled Open Label Clinical Study to Evaluate the Efficacy of Vyaghryadi Kashayam and Bharangi-Shunthi Churna in the Management of Shwasa Roga with special reference to Chronic Obstructive Pulmonary Disease COPD |
| 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 Manik Soni |
| Designation |
Senior Lecturer |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP) |
| Address |
Room number 317 hospital building Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola district Kangra
Room number 317 hospital building Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola district Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219121014 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr Sunil Thakur |
| Designation |
Professor and head |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP) |
| Address |
Room number 317 hospital building Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola district Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeksha Sharma |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola (HP) |
| Address |
Room number 317 hospital building Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola district Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018482481 |
| Fax |
|
| Email |
deekshasharma171198@gmail.com |
|
|
Source of Monetary or Material Support
|
| charak government ayurvedic pharmacy paprola district kangra, herbal garden and herbarium , research institute in ISM jogindernagar mandi |
|
|
Primary Sponsor
|
| Name |
RGGPG ayurvedic college and hospital |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital Paprola district Kangra HP |
| Type of Sponsor |
Government medical college |
|
|
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 Manik Soni |
RAJIV GANDHI GOVT. PG AYURVEDIC COLLEGE AND HOSPITAL PAPROLA HP |
Room no. 317 Hospital building Rajiv gandhi govt. PG Ayurvedic college and Hospital paprola Distt. Kangra (H.P)
Room no. 317 Hospital building Rajiv gandhi govt. PG Ayurvedic college and Hospital paprola Distt. Kangra (H.P.)
Kangra
HIMACHAL PRADESH |
8219121014
drmsony@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICS COMMITTEE (HUMAN) |
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: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyaghryadi Kashayam , Reference: A.Hr.Chi1/61, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Bharangi-Shunthi Churna, Reference: Chakradutta 12/8, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Doxofylline | 400 mg OD for the duration of 30 days. |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Willing to provide consent – Patients who voluntarily agree to participate and provide written informed consent.
2 Patients who fulfill the diagnostic criteria.
3 Patients of age group 40 - 70 years of either gender.
4 Patients who are in a stable phase of COPD ( not experiencing an acute exacerbation in the past 4 weeks).
5 Oxygen saturation (SPO2) more than or equal to 90 percent patients with adequate oxygenation levels without continuous oxygen therapy.
6 Mild to moderate COPD severity- patients with GOLD stage I to II (FEV1 more than or equal to 50 percent predicted but less than 80 percent).
|
|
| ExclusionCriteria |
| Details |
i. Patients not willing to participate in the trial.
ii. Patients presenting with complications like advanced Type II respiratory failure, lung collapse, pneumothorax.
iii. Patients suffering from other associated major illnesses like malignancy, pulmonary tuberculosis, renal failure, congestive heart failure, ischemic heart disease, severe anemia, myocardial infarction etc.
iv. Patients below 40 and above 70 years of age.
v. Pregnant and lactating women.
vi. Any other condition which the principal investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Vyaghryadi Kashayam and Bharangi-Shunthi Churna in the Management of Shwasa Roga w.s.r. to Chronic Obstructive Pulmonary Disease (COPD). |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. To compare the efficacy of Vyaghryadi Kashayam and Bharangi- Shunthi Churna
with Doxofylline.
ii. To assess the clinical safety of Vyaghryadi Kashayam and Bharangi-Shunthi Churna in the Management of Shwasa Roga w.s.r. to Chronic Obstructive Pulmonary Disease (COPD).
|
30 days |
|
|
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 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="0"
Months="0"
Days="30" |
|
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
|
The study is a randomized clinical trial planned in the post graduate department of kayachikitsa at paprola ayurvedic college . It aims to assess ayurvedic medicines in patients of shwasa roga which is clinically correlated with chronic obstructive pulmonary disease. The trial will evaluate vyaghryadi kashayam and bharangi shunthi churna which are described in classical ayurvedic texts and are believed to reduce kapha and vata related respiratory problems and improve breathing capacity . 30 patients between 40 to 70 years with stable chronic obstructive airway disease will be selected from outpatient and inpatient department. Eligible patients will be divided into 2 groups . one group will receive the vyaghryadi kashayam 40ml twice a day after meal and bharangi shunthi churna 3gm twice a day with lukewarm water and other group will receive doxofylline 400mg once in a day. Treatment duration will be 30 days with follow up after 15 days . Diagnosis and assessment will be based on clinical features of shwasa roga along with modern parameters like spirometery chest xray oxygen saturation and six minute walk test. improvement will be measured using symptoms scoring . Result will be analyzed statistically to understand the effect and safety of trial drugs. The aim is to generate scientific evidence regarding the usefulness of vyaghryadi kashyam and bharangi shunthi churna in managing shwasa roga. |