Home » Trials » SLCTR/2015/028
A phase II/III study of the anti-inflammatory activity of Rasna sapthakaya decoction in patients with rheumatoid arthritis
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SLCTR Registration Number
SLCTR/2015/028
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A phase II/III study of the anti-inflammatory activity of Rasna sapthakaya decoction in patients with rheumatoid arthritis
Public Title of Trial
A study on therapeutic efficacy of the herbal decoction Rasna sapthakya in patients with rheumatoid arthritis
Disease or Health Condition(s) Studied
Rhematoid arthritis
Scientific Acronym
None
Public Acronym
None
Brief title
Phase II/III study on Anti-inflammatory activity of Rasna sapthakaya decoction
Universal Trial Number
U1111-1175-4724
Any other number(s) assigned to the trial and issuing authority
ERC Sri Jayewardenepura Ref: 46/14
What is the research question being addressed?
What is the anti-inflammatory effect of the traditional Ayurvedic decoction Rasna sapthakaya in patients with rheumatoid arthritis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
The seven constituents of Rasna Sapthakaya (RS) decoction are
Alpinia calcarata - root
Tinospora cordifolia- stem
Cassia fistula- bark of the root
Boerhavia diffusa- root
Cedrus deodara – wood
Ricinus communis - root
Tribulus testretris- whole plant/root
The ingredients for the decoction (mentioned above) will be authenticated and the decoction prepared according to the conventional Ayurveda method.
60 patients with rheumatoid arthritis attending the clinic at the Ayurvedha Teaching Hospital, Borella will be recruited by advertisement displayed in the notice boards of the Hospital. Participants meeting inclusion/exclusion criteria will be randomised into two arms.
The patients in the intervention arm will be given 14 packets of ingredients of RS decoction. They will be instructed on the method of preparation of the decoction by the principal investigator and the method of preparation also will be provided in writing in their preferred languages. The patients will be advised to take ½ cup which is approximately 120 ml, in the morning and at night, daily for 14 days.
The patients on the control arm will receive the standard Ayurveda anti-inflammatory drug (Rumalaya tablet /500mg/ twice daily for 14 days) at a standard therapeutic dose
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline, day 15 and day 56 (end of two months) ] |
Secondary outcome(s)
|
1.
Selected side effects as recorded in a patient diary, including headache, nausea, vomiting, diarrhoea and allergic reactions ( itching, sneezing) |
[ At baseline, day 15 and day 56 (end of two months) ] |
Target number/sample size
60 (30 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-12-15
Anticipated end date
2016-02-29
Date of first enrollment
2015-12-01
Date of study completion
Recruitment status
Recruiting
Funding source
University Grants Commission (Grant number UGC/ICD/RG/02/2012/05)
Regulatory approvals
Status
Approved
Date of Approval
2015-10-29
Approval number
46/14
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.J.M. Dahanayake
Senior Lecturer
Department of Ayurveda Pharmacology and Pharmaceutics
Institute of Indigenous Medicine University of Colombo.
Mob: 071-5347043
jdahanayake@yahoo.com
Contact Person for Public Queries
Dr. Pathirage Kamal Perera
Senior Lecturer and Consultant in Pharmacology, Immune-medicine and Clinical products development and Head / Department of Ayurveda Pharmacology and Pharmaceutics
Institute of Indigenous Medicine, University of Colombo,
Rajagiriya, Sri Lanka
Mob: 071-6419072
drkamalperera@yahoo.com
Primary study sponsor/organization
University Grants Commission
No. 20,
Ward Place, Colombo 07
Sri Lanka
Tel: +94 11 2695301
Fax: +94 11 2688045
http://www.ugc.ac.lk/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
