Home » Trials » SLCTR/2011/001
The effect of daily dose of a herbal preparation (Link Samahan R) on the incidence and severity of upper respiratory symptoms in consenting adult healthy volunteers: an open label controlled trial
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SLCTR Registration Number
SLCTR/2011/001
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
The effect of daily dose of a herbal preparation (Link Samahan R) on the incidence and severity of upper respiratory symptoms in consenting adult healthy volunteers: an open label controlled trial
Public Title of Trial
A trial of a herbal preparation (Link Samahan R) on the incidence of upper respiratory symptoms
Disease or Health Condition(s) Studied
Upper respiratory symptoms
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
(ERC/ 10-014) Ethical Review Committee of the Sri Lanka Medical Association)
What is the research question being addressed?
Does a daily dose of Link Samahan reduce the incidence of upper respiratory symptoms in healthy people?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Prevention
Study Phase
Not Available
Intervention(s) planned
Giving one packet of Link Samahan R daily for 3 months
Inclusion criteria
All consenting healthy adults between 20 and 50 years old employed at MAS Linea Aqua (Pvt.) Ltd.
Exclusion criteria
Pregnant and breast feeding women
Primary outcome(s)
|
1.
Incidence of defined upper respirartory symptoms |
[ Incidence of defined upper respiratory symptoms will be recorded in control and test groups for 120 days ] |
Secondary outcome(s)
|
1.
Severity of upper respiratory symptoms |
[ Over 120 consecutive days ] |
Target number/sample size
800 participants
Countries of recruitment
Sri Lanka
Anticipated start date
2011-01-21
Anticipated end date
2011-09-30
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Link Natural Products (Pvt.) Ltd.
Regulatory approvals
Status
Approved
Date of Approval
2010-12-02
Approval number
ERC/10-014
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association, |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Professor. Colvin Goonaratna
Registrar, Ceylon Medical College Council
Faculty of Medicine, Colombo 8,
4612643
si7np5e@gmail.com
Contact Person for Public Queries
Professor. Colvin Goonaratna
Registrar, Ceylon Medical College Council
Faculty of Medicine, Colombo 8,
4612643
si7np5e@gmail.com
Primary study sponsor/organization
Link Natural Products (Pvt.) Ltd.
Malinda, Kapugoda
2409294 2409293
rd@linknaturalproducts.com
www.linknaturalproducts.com
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
