| CTRI Number |
CTRI/2023/11/059565 [Registered on: 06/11/2023] Trial Registered Prospectively |
| Last Modified On: |
03/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial To study the effect of Bharangyadi Kwatha & Kaliphala Churna in the management of Shwasa roga w.s.r. To COPD
|
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Bharangyadi Kwatha & Kaliphala Churna in the management of Shwasa Roga w.s.r. 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 |
Prof Anjana Mishra |
| Designation |
Head of the Department |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital |
| Address |
Room No 317 of Kayachikitsa Department in Hospital building in Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Thakur |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola |
| Address |
Room No 317 of Kayachikitsa Department in Hospital building in Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Kaushal |
| Designation |
P. G. Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital, Paprola |
| Address |
Room No 317 of Kayachikitsa Department in Hospital building in Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418467160 |
| Fax |
|
| Email |
kamalkaushal54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital, Paprola |
|
|
Primary Sponsor
|
| Name |
Dr Anjana Mishra |
| Address |
Room no 217 Anatomy block Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
| 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 Anjana Mishra |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
Room No 317 of Kayachikitsa Department in Hospital Building
Kangra
HIMACHAL PRADESH |
9418312324
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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: Kaliphala churna , Reference: Chakradatt 12/18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bharangyadi kwatha , Reference: Yoga ratnakar 432/6, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Prolonged expiration with pursed lip breathing, barrel shaped chest, central or peripheral cyanosis, diminished expansion of chest,use of accessory muscles |
|
| ExclusionCriteria |
| Details |
Patients presenting with complications like advanced type 2 respiratory failure, lung collapse and pneumothorax
Patients showing more than 12% increment in FEV1/FVC ratio after bronchodilation with 2 puffs of salbutamol 100mcg/puff |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A clinical study to evaluate the effect of Bharangyadi Kwatha & Kaliphala churna in the management of Shwasa Roga w.s.r. to Chronic obstructive Pulmonary Disease (COPD)
To compare the effect of Bharangyadi Kwatha and Kaliphala Churna with Doxophylline in the management of Shwasa Roga w.s.r.to Chronic Obstructive Pulmonary Disease (COPD) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety of Bharangyadi Kwatha & Kaliphala 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 2 |
|
Date of First Enrollment (India)
|
20/11/2023 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
I wish to publish my research work after completion of my trial. A total no of 30 patients will be selected from OPD and IPD of Kayachikitsa Department in Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola Distt Kangra, H.P. Two groups of 15 patients each will be managed with bharangyadi kwatha and kaliphala churna respectively in the management of Shwasa roga w. s. r. To Chronic obstructive Pulmonary Disease. |