| CTRI Number |
CTRI/2024/08/072946 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to determine efficacy of Mahaushadhi Kwatha and Simhanada Guggulu in Amavata. |
|
Scientific Title of Study
|
A comparative clinical study to determine the efficacy of Mahaushadhi Kwatha and Simhanada Guggulu in the management of Amavata w.s.r. to Rheumatoid Arthritis. |
| 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 Sunil Thakur |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetika Dharmani |
| Designation |
AMO |
| Affiliation |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola Distt Kangra |
| Address |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018817072 |
| Fax |
|
| Email |
Dr.geeti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikram Singh |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola Distt Kangra |
| Address |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418962821 |
| Fax |
|
| Email |
Vikramviki821@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy RGGPG Ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh 176115 |
|
|
Primary Sponsor
|
| Name |
Principal Rajiv Gandhi Government Ayurvedic College and Hospital Paprola District Kangra |
| Address |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh 176115 |
| 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 |
| Vikram Singh |
RAJIV GANDHI GOVT POST GRADUATE AYURVEDIC COLLEGE & HOSPITAL PAPROLA DISTT KANGRA (HP) 176115 |
Rajiv Gandhi Govt Post Graduate ayurvedic College and Hospital Paprola Distt Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH |
9418961821
Vikramviki821@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhanada Guggulu, Reference: Chakradutta, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahaushadhi kwatha, Reference: yogratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients having morning stiffness with arthritis of hands or 3 or more symmetrical joints and positive rheumatoid factor |
|
| ExclusionCriteria |
| Details |
patients below age of 30 and above 70 years or suffering from chronic cardiac , respiratory illness,PTB , malignancy and pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To relieve the signs and symptoms of rheumatoid arthritis such as angmarda aruchi daha sandhi shool sparsh ashyata |
To relieve the signs and symptoms of rheumatoid arthritis such as angmarda aruchi daha sandhi shool sparsh ashyata |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find untoward effects of the drug |
8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="2"
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 would like to publish my trial work after completion of trial in the form of thesis. |