| CTRI Number |
CTRI/2023/11/059780 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
13/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A study on management of rheumatoid arthritis using siddha medicine maha analuruva chooranam |
|
Scientific Title of Study
|
Phase II non randomized open clinical evaluation of siddha medicine maha analuruva chooranam for the management of uthiravatha suronitham (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 |
Dharani P |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college, Arumbakkam, Chennai 106. |
| Address |
Post graduate department of pothu maruthuvam, Government siddha medical college, Arumbakkam,
Chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
8940122580 |
| Fax |
|
| Email |
drdharanipoomalai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra U |
| Designation |
Lecturer |
| Affiliation |
Government siddha medical college, Arumbakkam, Chennai 106. |
| Address |
Post graduate department of pothu maruthuvam, Government siddha medical college, Arumbakkam,
Chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9445716802 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharani P |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college, Arumbakkam, Chennai 106. |
| Address |
Post graduate department of pothu maruthuvam, Government siddha medical college, Arumbakkam,
Chennai 106.
Chennai
TAMIL NADU
600106
India |
| Phone |
8940122580 |
| Fax |
|
| Email |
drdharanipoomalai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college, Arumbakkam,
Chennai 106. |
|
|
Primary Sponsor
|
| Name |
Dr Dharani P |
| Address |
Post graduate department of pothu maruthuvam, Government siddha medical college, Arumbakkam,
Chennai 106. |
| Type of Sponsor |
Other [Self] |
|
|
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 Dharani P |
Arignar anna government hospital of Indian medicine |
Room number S1,Post graduate department of pothu maruthuvam, Government siddha medical college, Arumbakkam,
Chennai 106.
Chennai
TAMIL NADU |
8940122580
drdharanipoomalai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M060||Rheumatoid arthritis without rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MAHA ANALURUVA CHOORANAM |
This is a siddha herbal medicine for the management of Rheumatoid arthritis.It will be given as oral route in the dose of 1.5 gm (BD) with honey for the duration of 48 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age limit - 18 to 50 years
All genders
Morning stiffness more than 1 hour
Arthritis of more than 3 joints
Symmetrical arthritis
Patients positive for anti-CCP |
|
| ExclusionCriteria |
| Details |
Rheumatic fever
Psoriatic arthropathy
Gouty athritis
Any other serious systemic illness
Pregnant women and lactating mothers
Type 2 diabetes mellitus
The above criteria will be excluded clinically or based on the available medical reports. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be mainly assessed by reduction in clinical symptoms such as severity of pain,reduction of swelling and morning stiffness. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assesing the improvement of patient from severe to moderate,moderate to mild through universal pain assessment scale (VISUAL ANALOGUE SCALE) and reduction in Anti-CCP levels which helps to ensure the wellness of patient. |
7 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/11/2023 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drdharanipoomalai@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 01-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rheumatoid arthritis is an auto immune disorder and a chronic multisystem disease, with a variety of systemic manifestations.The prevalence of RA in India is 0.5-0.75 %. Females are more affected than male in the ratio of 3:1. Thus in Siddha system of medicine, there are unique combinations of medicine which have the solution to RA. One such combination is MAHA ANALURUVA CHOORANAM which will be cost effective and reliable. The aim of the study is the management of UTHIRAVATHA SURONITHAM compared with RHEUMATOID ARTHRITIS with the Siddha medicine MAHA ANALURUVA CHOORANAM and the objective is to determine the therapeutic efficacy and safety profile of Siddha medicine MAHA ANALURUVA CHOORANAM in the treatment of UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS ) As the literary evidences support the usage of medicine in the disease, a hyopothesis is created in such a way that the efficacy of the MAHA ANALURUVA CHOORANAM will be better solution for UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS). |