| CTRI Number |
CTRI/2017/04/008419 [Registered on: 26/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effect of ginger in the management of Rheumatoid arthritis |
|
Scientific Title of Study
|
"A Pharmaco-clinical Study Of Shunthi(Zingiber officinale Roxb) Churna in the Management of Amavata(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 |
Milan Jayantibhai Prajapati |
| Designation |
M D Student |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9724575599 |
| Fax |
|
| Email |
drmilanprajapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Milan Jayantibhai Prajapati |
| Designation |
M D Student |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9724575599 |
| Fax |
|
| Email |
drmilanprajapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Milan Jayantibhai Prajapati |
| Designation |
M D Student |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara
Vadodara
GUJARAT
390025
India |
| Phone |
9724575599 |
| Fax |
|
| Email |
drmilanprajapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara |
| Type of Sponsor |
Private 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 Anil Pandya |
Parul Sevaashram Hospital |
Parul University
Parul Institute Of Ayurved
Dravyaguna Department
Room No 201
At and Po Limda
Ta Waghodia
Di Vadodara
Vadodara
GUJARAT |
9714749265
dranilpandya1254@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Parul Institute Of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who are suffering from Amavata (Rheumatoid Arthritis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
SHUNTHI CHURNA |
2 gm/ day for 1 month |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical signs and symptoms of Amavata will be selected for study |
|
| ExclusionCriteria |
| Details |
Systemic disorders like cardiac disease, DM,HTN, Cancer, Respiratory disease
More than 10 years old disease
Asadhya laxan of amavata |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the signs and symptoms of Amavata will be assigned score depending upone their severity to assess the effect of the drugs at the time of before treatment and after treatment. |
With time period of 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
16/03/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised, active controlled trial to study the efficacy of sunthi churna in the management of Amavata ( Rheumatoid Arthritis) in the dose of 2gram/ day with vehicle of usnodaka for the duration of 1 month in 30 patients of Amavata will be conducted in india. This study will evaluate Anti-inflammatory effect of Ginger. |