| CTRI Number |
CTRI/2017/02/007869 [Registered on: 15/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
04/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
management of rheumatoid arthritis with Ayurvedic drugs. |
|
Scientific Title of Study
|
A Comparative clinical study of Pathyadi churna ad Amrutadi churna in the manangement of Amavat(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 |
Meera Hemant Kotak |
| Designation |
P.G.student |
| Affiliation |
Govt, akhandanand ayurved college and hospital |
| Address |
R.D.L.84/984 chanod colony, silvassa road, G.I.D.C. vapi
Upgraded kayachikitsa department
Govt, akhandanand ayurved college and hospital
Lal darwaja
Bhadra
Ahmadabad
GUJARAT
396195
India |
| Phone |
9408188530 |
| Fax |
|
| Email |
meerakotak97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mustak Shaikh |
| Designation |
Lecturer (M.D.kayachikitsa) |
| Affiliation |
Govt. Akhandanand Ayurved college and hospital |
| Address |
Govt. Akhandanand Ayurved college and hospital,Bhadra Ahmedabad Gujarat 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824440708 |
| Fax |
|
| Email |
mustakshaikh11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mustak Shaikh |
| Designation |
Lecturer (M.D.kayachikitsa) |
| Affiliation |
Govt. Akhandanand Ayurved college and hospital |
| Address |
Govt. Akhandanand Ayurved college and hospital,Bhadra Ahmedabad Gujarat 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824440708 |
| Fax |
|
| Email |
mustakshaikh11@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Govt. Akhandanand Ayurved college and hospital and Maniben Ayurved hospital,Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurved college and hospital and Maniben Ayurved Hospital |
| Address |
O.P.D. of kayachikitsa department Govt. Akhandanand Ayurved college and hospital, Ahmedabad and Maniben Ayurved Hospital,Asarva Ahmedabad Gujarat 380001 |
| 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 Meera Hemant Kotak |
Govt. Akhandanand Ayurved college and hospital |
O.P.D.No.9
Dept.-Kayachikitsa
Ahmadabad
GUJARAT |
9408188530
meerakotak97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commttee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Amavata(Rheumatoid arthritis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amrutadi churna |
Patients will be advised to take Amrutadi churna orally under strict dos and donts mentioned by acharyas in classical texts in dose of 4 gm thrice a day with lukewarm water for period of 6 weeks.
Time of administration- Before meal
|
| Intervention |
Pathyadi churna |
Patients will be advised to take pathyadi churna orally under strict dos and donts mentioned by acharyas in classical texts in dose of 4 gm thrice a day with lukewarm water for period of 6 weeks.
Time of administration- Before meal
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having 3 or more classical signs and symptoms of Amavata mentioned in Madhav nidana will be selected.
The base of criteria led down by American Rheumatism Association:
Morning stiffness lasting for more than one hour.
Arthritis of 3 or more joint areas.
Symmetrical arthritis.
Presence of Rheumatoid nodules.
Presence of Rheumatoid factor.
First 4 criteria must be present for duration of 6 weeks or more.
Diagnosis of rheumatoid arthritis will be made with 4 or more criteria. |
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic disorders like cardiac diseases, cancer, tuberculosis and other debilitating diseases which may lead to fatal condition at any time.
Patients of chronic condition (more than 3 years)
Deformity like ulnar deviation, swan neck, etc.
Asadhya lakshanas as Sarva deha chara shotha mentioned in classical texts. |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in inflammatory swelling, pain and time duration of stiffness in morning. |
After 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in inflammatory swelling, pain and time duration of stiffness in morning. |
After 6 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)
|
03/08/2016 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized parallel group trial being conducted in Govt. Akhandanand Ayurved college and hospital, Ahmedabad Gujarat. Despite of administration of best modern medicines Rheumatoid arthritis have the tendency of persisting progress. Its signs and symptoms are similar to Amavata mentioned in Ayurveda classics. Acharyas have mentioned mandagni as the root cause of Amavata in which he has advised to administer langhana and drugs having deepana pachana properties. Pathyadi churna and Amrutadi churna are drugs having such properties. Therefore, in present study Pathyadi churna has been selected for clinical trial in group A and Amrutadi churna as group B. Group A: Approx 15 patients, will be administered Pathyadi churna in dose of 4 gm thrice a day before meal with lukewarm water for 6 weeks. Group B: Approx 15 patients, will be administered Amrutadi churna in dose of 4 gm thrice a day before meal with lukewarm water for 6 weeks. |