| CTRI Number |
CTRI/2021/12/038439 [Registered on: 06/12/2021] Trial Registered Prospectively |
| Last Modified On: |
04/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
use of shiva guugul and virechan in rheumatic arthritis |
|
Scientific Title of Study
|
A study to evaluate the therapeutic efficacy of Shiva Guggulu along withVirechan karma in the management of Aamvata (Rheumatoid Arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MOHINI GUPTA |
| Designation |
MD SCHOLAR |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. (AUTONOMUS) AYURVEDA COLLEGE AND INSTITUTE BHOPAL (M.P.) |
| Address |
PG DEPARTMENT OF KAYACHIKITSA
PT. KHUSHILAL SHARMA GOVT. (AUTONOMUS) AYURVEDA
COLLEGE AND INSTITUTE BHOPAL (M.P.)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9425984611 |
| Fax |
|
| Email |
mguever8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIVEK SHARMA |
| Designation |
LECTURE |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. (AUTONOMUS) AYURVEDA COLLEGE AND INSTITUTE BHOPAL (M.P.) |
| Address |
PG DEPARTMENT OF KAYACHIKITSA
PT. KHUSHILAL SHARMA GOVT. (AUTONOMUS) AYURVEDA
COLLEGE AND INSTITUTE BHOPAL (M.P.)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827937247 |
| Fax |
|
| Email |
drvivek.sharma13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIVEK SHARMA |
| Designation |
LECTURE |
| Affiliation |
PT. KHUSHILAL SHARMA GOVT. (AUTONOMUS) AYURVEDA COLLEGE AND INSTITUTE BHOPAL (M.P.) |
| Address |
PG DEPARTMENT OF KAYACHIKITSA
PT. KHUSHILAL SHARMA GOVT. (AUTONOMUS) AYURVEDA
COLLEGE AND INSTITUTE BHOPAL (M.P.)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827937247 |
| Fax |
|
| Email |
drvivek.sharma13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PtKhushilal Sharma Govt Autonomus College and Institute Bhopal MP |
| Address |
PG DEPARTMENT OF KAYACHIKITSA
PT. KHUSHILAL SHARMA GOVT. (AUTONOMUS) AYURVEDA
COLLEGE AND INSTITUTE BHOPAL (M.P.)
|
| Type of Sponsor |
Government funding agency |
|
|
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 MOHINI GUPTA |
PTKHUSHILALSHARMAGOVT (AUTONOMUOS)AYURVED COLLEGEAND INSTITUTEBHOPAL MADHYAPRADESH |
PG DEPARTMENT OF KAYACHIKITSA
Bhopal
MADHYA PRADESH |
9425984611
mguever8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC),College: Pt. Khushilal Sharma Govt.(Autonomous) Ayurved College &Institute City: Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M060||Rheumatoid arthritis without rheumatoid factor. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shiva Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
.Age between 35 – 65 years of either sex.
.Patients fulfilling the American college of Rheumatology 2010 revised criterias of RA. .Patients willing to sign written consent form for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1. Age below 35 and above 65 years.
2. Patients who develop secondary complication of RA e.g. Pleuro-pericardial disease, severely damagedjoint with bed ridden patients.
3. Any other serious illness e.g. Hepatic/ renal failure.
4. Patient with diagnosed other arthritis like Gouty arthritis, tuberculosis arthritis etc.
5. Patient receiving any other method of treatment.
6. Patients having severe crippling deformities.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study , we would be able to demonstrate and explain the efficacy of Shiva guggulu along with Virechan Karma in the management of Aamvat (RA). |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of the study , we would be able to demonstrate and explain the efficacy of Shiva guggulu along with Virechan Karma in the management of Aamvat (RA). |
11 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2021 |
| Date of Study Completion (India) |
04/07/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/07/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
AT THE END OF THE STUDY, WE WOULD BE ABLE TO DEMONSTRATE AND EXPLAIN THE EFFICACY OF SHIVA GUGGULU ALONG WITH VIRECHAN KARMA IN THE MANAGEMENT OF AAMAVAT (RA). |