| CTRI Number |
CTRI/2011/10/002058 [Registered on: 12/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
22/09/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Siddha Medicine for Uthiravadha Suronitham (Rheumatoid Arthiritis ) |
|
Scientific Title of Study
|
A PILOT STUDY TO EVALUATE THE THERAPEUTIC EFFICACY OF SIDDHA HERBO MINERAL FORMULATION RAJA LOGA NATHA RASA PARPAM INTERNAL and AATTHIRADHI THAILAM EXTERNAL IN UTHIRAVATHASURONITHAM 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 |
Ramya |
| Designation |
Pg Scholar |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NO 5/55 THIRUVALLUVAR NAGAR
2 ND CROSS
KRISHNAGIRI
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI-47
Kancheepuram
TAMIL NADU
635001
India |
| Phone |
9894538563 |
| Fax |
9104422381314 |
| Email |
ramyabsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRSRamaswamy |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI-47
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI-47
Kancheepuram
TAMIL NADU
6000047
India |
| Phone |
9444941489 |
| Fax |
9104422381314 |
| Email |
dr.rsramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRSRamaswamy |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI-47
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI-47
Kancheepuram
TAMIL NADU
6000047
India |
| Phone |
9444941489 |
| Fax |
9104422381314 |
| Email |
dr.rsramaswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47 |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NATIONAL INSTITUTE OF SIDDHA |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSRamya |
NATIONAL INSTITUTE OF SIDDHA |
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI 47
Kancheepuram
TAMIL NADU |
9894538563
9104422381314
ramyabsms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, National Institute of Siddha, Chennai-47 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Rhematoid Arthritis (Uthira Vatha Suronitham), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Raja loga natha rasa parpam(Internal)
2.Aathiradhi thailam (External) |
1.250 mgs bid with pepper powder and cows ghee
2.2 drops in each nostrils (Nasiyam) and also external application |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Symmetrical joint involvement
• Arthritis of 3 or more joints
• Rheumatoid factor positive or negative
• Morning stiffness.
• Swelling especially in the inter-phalangeal joint.
• Patients who are willing for admission and stay in IPD for 48 days or willing to attend OPD
|
|
| ExclusionCriteria |
| Details |
• Hypertension and other Cardiac ailments
• Diabetes mellitus
• Narcotics
• Alcoholics and smokers.
• Pregnancy and lactation
• History of trauma
• Neurological disorder
• Tuberculosis
• Any other serious illness
• Psoriatic arthritis
• Gouty arthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome is aimed at reducing the pain and restricted joint movements.
Pain is assessed by Universal pain assessment scale.
|
0th day and 49th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ESR,RA factor,CRP |
0TH AND 49TH DAY |
|
|
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)
|
18/01/2011 |
| 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
|
No previous publication on the intervention |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a single arm trial to evaluate the efficacy of siddha herbo mineral formulation Raja Loga Natha Rasa Parpam - internal drug 250mgs twice a day with pepper powder and ghee along with Aathiradhi thailam - External drug also given as nasal drops (Nasiyam) in Rheumatoid arthiritis (Uthiravadha suronitham).The internal drug consists of rasam(purifiedmercury),Gandhagam(purified sulphur),Sangu(conch shell) and Palagarai(marine shell).The external drug consists of sesame oil,gadi(Vineger),Thayir thelivu( supernatent of curd),Adhimadhuram,Indhuppu,Inji,Chukku,Aanai thippili and Vaai vidangam.The internal drug is selected from the text Prana Rakshamirdha Sindhu and External drug is taken from the text Agasthiyar Vaidhya Chinthamani ( authenticated text books for siddha medicine).There has been no clinical trial carried out till today with the above mentioned drugs.Hence the investigator proposed this trial. |