| CTRI Number |
CTRI/2021/01/030640 [Registered on: 20/01/2021] Trial Registered Prospectively |
| Last Modified On: |
04/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Haritakyadi Gutika and Vasadi Kwatha in Shwasa Rog(COPD) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the effect of Haritakyadi Gutika and Vasadi Kwatha in the Management of Shwasa Roga w.s.r. to Chronic Obstructive Pulmonary Disease(COPD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Thakur |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola,Department of Kayachikitsa, Room no. - 315, VPO Paprola,
Teh. Baijnath, Distt. Kangra (HP)
RGGPG Ayurvedic College and Hospital Paprola, Department of Kayachikitsa,Room no.- 315, VPO Paprola
Teh. Baijnath , Distt. Kangra (HP)
Pin code 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Thakur |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, Department of Kayachikitsa, Room no. - 315, VPO Paprola, Teh. Baijnath, Distt. Kangra (HP)
RGGPG Ayurvedic College and Hospital Paprola, Department of Kayachikitsa, Room no. - 315, VPO Paprola, Teh. Baijnath, Distt. Kangra (HP)
Pin code 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Bhatt |
| Designation |
PG Student, Department of Kayachikitsa |
| Affiliation |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, Department of Kayachikitsa, Room no. - 315, VPO Paprola
Teh. Baijnath, Distt. Kangra (HP)
RGGPG Ayurvedic College and Hospital Paprola, Department of Kayachikitsa, Room no. - 315, VPO Paprola
Teh. Baijnath, Distt. Kangra (HP)
Pin code 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8988864676 |
| Fax |
|
| Email |
bhattpriyanka1797@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy, Paprola, Teh. - Baijanth, District kangra, Himachal Pradesh, PIN - 176115 |
| Charak Pharmacy, Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola,Teh. Baijnath, District -Kangra, Himachal Pradesh, PIN - 176115
|
| Research institute I.S.M. Jogindernagar,Teh. - Jogindernagar, Distt. - Mandi Himachal Pradesh, PIN - 175015 |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and Hospital Paprola |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, Teh. Baijnath, Distt. Kangra, Himachal Pradesh, PIN - 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Department of Kayachikitsa RGGPG Ayurvedic College and Hospital Paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Thakur |
RGGPG Ayurvedic College and Hospital Paprola |
Room no. - 315, Department of Kayachikitsa, RGGPG Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH |
9816195001
dr.skumarthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (Human) RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition:J449||Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: शवास रोग, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Doxofylline |
Tab Doxofylline 400 mg once a day |
| Intervention |
Haritakyadi Gutika and Vasadi Kwatha |
Haritakyadi Gutika:- 1 gm twice a day for 30 days,
Vasadi Kwatha:- 50 ml twice a day for 30 days |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing for trial.
2.Patients ready to give written consent.
3.Patient who fulfill the diagnostic criteria.
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the trial.
2.Patients presenting complications like advanced Type 2 respiratory failure, lung collapse, pneumothorax etc.
3.Patients suffering from other associated major illness like malignancy, pulmonary tuberculosis, renal failure, diabetes mellitus, congestive heart failure, ischemic heart disease, severe anaemia, myocardial infarction, poorly controlled hypertension etc.
4.Patients below 45 and above 75.
5.More than 12% increment in FEV1/FVC after bronchodilation with 200 mcg Salbutamol. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of subjective and objective criteria |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well being |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/01/2021 |
| Date of Study Completion (India) |
15/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
I would like to publish my research trial after completion of the trial as soon as possible. The patients will be selected from OPD and IPD of department of Kayachikitsa of RGGPG Ayurvedic College and Paprola. Total 30 patients will be registered and then assessed on the basis of subjective and objective parameters after the completion of therapy. |