Home » Trials » SLCTR/2015/005
A phase I study of the safety/ possible toxicity of a novel Ayurvedic preparation, Sudarshana Suspension.
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SLCTR Registration Number
SLCTR/2015/005
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A phase I study of the safety/ possible toxicity of a novel Ayurvedic preparation, Sudarshana Suspension.
Public Title of Trial
Safety/toxicity evaluation of a new Ayurveda drug formulation Sudarshana Suspension
Disease or Health Condition(s) Studied
Fever (proposed indication)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1167-0783
Any other number(s) assigned to the trial and issuing authority
Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura : No 775 /13 Ethics Review Committee, Institute of Indigenous Medicine, University of Colombo : No ERC 12/11
What is the research question being addressed?
What is the effect of the novel preparation, Sudarshana suspension 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
Healthy adult volunteers will be recruited by an open advertisement displayed in the notice boards of the University of Sri Jayewardenepura and Institute of Indigenous Medicine, University of Colombo.
Participants will receive approximately 37ml of the novel preparation at six hourly intervals (four daily doses) for 7 consecutive days. Dose calculation will be based on body weight (10/16 x 60kg body weight = 37 ml)
Sudarshana Powder (SP) mixed with and bees honey according to Ayurveda Authentic texts will be used in this novel preparation. No other excipients will be used.
Sudarshana Powder contains Andrographis paniculata (Burm. F.) Nees (50%) along with other 52 ingredients (50%), and is prepared according to the standard Ayurvedic formulation.
Inclusion criteria
1.Age group of 18-60 years at the time of enrollment, of either sex with weight less than 60kg 2.Those who have no known systemic disorders, such as hypertension, diabetes mellitus, hypercholesterolemia and chronic arthritis 3. Those who have no history of drug allergy. 4.Those who have no history of intolerance to Sudarshana Powder or similar compounds 5. Women should be non pregnant and non breast feeding. 6. Only those who can write and read languages of English or Sinhala.
Exclusion criteria
Concurrent treatment with any Ayurveda or Western medicine
Primary outcome(s)
|
1.
Changes in the following bio-markers Volunteers will be requested to maintain the diary recording noting the time of drug administration, any unusual symptoms (vomiting, headache, diarrhoea) and time of onset and duration of the symptoms during the treatment period and follow up period. |
[ In each subject, basic epidemiological and anthropometric data (age, sex, weight) including visit check list will be recorded by the principal investigator and also the volunteer diary will be recorded by the volunteer ] |
Secondary outcome(s)
|
1.
After successive intervention of phase I , phase II studies will be planned according to ERC approval. |
[ At baseline, day 3 and day 8 ] |
Target number/sample size
35 (Statistically determined)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-03-02
Anticipated end date
2015-05-01
Date of first enrollment
2015-03-09
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
HETC project ,Ministry of Higher Education– CMB/IIM/N4
Regulatory approvals
Status
Approved
Date of Approval
2015-01-22
Approval number
775 /13
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. W.A.S.S.Weerakoon
Lecturer and Consultant Ayurvedic Paediatrician
Department of Ayurveda Paediatrics, Institute of Indigenous Medicine, University of Colombo
Tel: 0112694308
Mob: 0714500031
sarojaweerakoon@yahoo.com
Contact Person for Public Queries
Dr. T.S.Suresh
Senior Lecturer Grade I
Depart of Biochemistry, Faculty of Medical Sciences, University of Sri Jayewardenepura
Tel: 0112758594
Mob: 0777314565
malalavidhane@yahoo.com
Primary study sponsor/organization
HETC Project, Ministry of Higher Education
Higher Education for 21st Century Project
Address 23 /135, Diyawanna Gardens, Chandra Silva Mawatha, Nugegoda, Sri Lanka
00941122852266
0094112814283
ppdu@hetc.lk
www.hetc.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
