Home » Trials » SLCTR/2013/036
The effects of a herbal medicinal product, Swastha Thriphala, on the side effects of chemotherapy and radiotherapy in patients with cancer
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SLCTR Registration Number
SLCTR/2013/036
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
The effects of a herbal medicinal product, Swastha Thriphala, on the side effects of chemotherapy and radiotherapy in patients with cancer
Public Title of Trial
The effect of Swastha Thriphala, an Ayurveda medicinal formulation on side-effects of therapy and quality of life in cancer patients
Disease or Health Condition(s) Studied
Side effects of chemotherapy and radiotherapy in cancer
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the effect of Swastha Thriphala,a herbal medicinal product on the side effects of chemotherapy and radiotherapy in patients with cancer ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Participants will be randomized into two arms.
The intervention arm will receive Swastha Thriphala 750g to be taken orally twice daily for 30 days.
The control arm will receive a standardized placebo one tablet to be taken orally twice daily for 30 days.
Inclusion criteria
Exclusion criteria
Patients with diagnosed 1. Heart failure 2. Chronic kidney diseases 3. Respiratory diseases 4. Chronic liver diseases 5. Stroke 6. Dementia 7. Frailty 8. Parkinson disease
Primary outcome(s)
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1.
Haematological side effects (changes in neutrophil count, haemoglobin and platelets) |
[ Baseline, 3 days, 7 days, 14 days and 30 days of treatment ] |
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2.
Patient assessment of fatigue, sleep and hair loss |
[ Baseline, 3 days, 7 days, 14 days and 30 days of treatment ] |
Secondary outcome(s)
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1.
None |
[ None ] |
Target number/sample size
200
Countries of recruitment
Sri Lanka
Anticipated start date
2013-12-30
Anticipated end date
2014-10-21
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Link Natural Products (Pvt) Ltd , Malinda, Kapugoda, Sri Lanka Tel: +94 0112409294 Fax :+94 0112409293 E-Mail : info@linknaturalproducts .com Website : www.linknaturalproducts.com
Regulatory approvals
Status
Approved
Date of Approval
2013-02-12
Approval number
Not available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Professor Colvin Goonaratna
Registrar
CMCC, Faculty of Medicine,Colombo 8
4 612 643
0773 761 205
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si7np5e@gmail.com
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Contact Person for Public Queries
Dr. J Haradugoda
Consultant Oncologist
Oncology Unit
Teaching Hospital
Karapitiya.
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077-7666335
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drhemanthi2002@yahoo.co.uk
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Primary study sponsor/organization
Link Natural Products (Pvt) Ltd
CIC House,199, Kew Road, Colombo 02. Sri Lanka
Factory :Giridara Road, Malinda, Kapugoda, Sri Lanka
0112409294
0112409293
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
