Home » Trials » SLCTR/2015/006
A phase I study of the possible toxicity of the Ayurvedic preparation, Rasna Sapthakaya
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SLCTR Registration Number
SLCTR/2015/006
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A phase I study of the possible toxicity of the Ayurvedic preparation, Rasna Sapthakaya
Public Title of Trial
A study of the Ayurvedic preparation Rasna Sapthakaya decoction in healthy volunteers
Disease or Health Condition(s) Studied
Chronic arthritis (proposed indication)
Scientific Acronym
None
Public Acronym
None
Brief title
Study on Safety profile of Rasna sapthakaya decoction
Universal Trial Number
U1111-1157-0026
Any other number(s) assigned to the trial and issuing authority
46/14 (University of Sri Jayewardenepura)
What is the research question being addressed?
What is the effect of the Ayurvedic preparation Rasna sapthakaya on selected safety bio-markers in healthy adult volunteers?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Other
Study Phase
Phase 1
Intervention(s) planned
The seven constituents of Rasna Sapthakaya decoction are;
In addition to this decoction, dried ginger powder is taken (dissolved) as a vehicle. The ingredients for the decoction (mentioned above) will be authenticated and the decoction prepared according to the conventional Ayurvedha method.
The study setting will be the Faculty of Medical Sciences, University of Sri Jayawardenepura and the Institute of Indegenous Medicine, University of Colombo
Healthy volunteers will be recruited by an open advertisement.
The healthy volunteer participants will be instructed to consume 240 ml of decoction (120 ml in the morning and 120 ml in the night) for 14 consecutive days. Freshly prepared decoction will be given to the participants daily by the principal investigator.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
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1.
Serum Alanine transferase (ALT) |
[ At baseline, Day 8 and Day 15 ] |
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2.
Serum Aspartate transferase (AST) |
[ At baseline, Day 8 and Day 15 ] |
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3.
Serum Alkaline phosphatase (ALP) |
[ At baseline, Day 8 and Day 15 ] |
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4.
Serum creatinine |
[ At baseline, Day 8 and Day 15 ] |
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5.
Blood urea |
[ At baseline, Day 8 and Day 15 ] |
Secondary outcome(s)
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1.
Selected side effects as recorded in a patient diary, including headache, nausea, vomiting, diarrhoea and allergic reactions ( itching, sneezing) |
[ At baseline, Day 8 and Day 15 ] |
Target number/sample size
30
Countries of recruitment
Sri Lanka
Anticipated start date
2015-03-02
Anticipated end date
2015-09-30
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
University Grants Commission (Grant number UGC/ICD/RG/02/2012/05)
Regulatory approvals
Status
Approved
Date of Approval
2014-06-24
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
Mrs. Rajavarthani Sanjeev
Lecturer
Department of Human Biology,
Faculty of Health-Care Sciences
Eastern University, Sri Lanka
Mob: 071-8063973
r_varthani@yahoo.com
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Contact Person for Public Queries
Dr. Mrs. Sugandhika Suresh
Senior Lecturer
Department of Biochemistry
Faculty of Medical Sciences
Sri Jayewardenepura University, Sri Lanka
Tel: 0112758594
Mob: 0777-314565
malalavidhane@yahoo.com
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Primary study sponsor/organization
University Grants Commision, Sri Lanka
University Grants Commission
Ward Place
Colombo 07
www.ugc.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
