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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
SLCTR/2015/006 |
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Date of registration:
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2015-03-02 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A study of the Ayurvedic preparation Rasna Sapthakaya decoction in healthy volunteers
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Scientific title:
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A phase I study of the possible toxicity of the Ayurvedic preparation, Rasna Sapthakaya |
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Date of first enrolment:
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2015-03-02 |
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Target sample size:
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30 |
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Recruitment status: |
Complete: follow up complete |
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URL:
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https://slctr.lk/trials/slctr-2015-006 |
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Study type:
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Interventional |
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Study design:
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Single arm study
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Phase:
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Phase 1
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Mrs. Rajavarthani Sanjeev
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Address:
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Department of Human Biology,
Faculty of Health-Care Sciences
Eastern University, Sri Lanka
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Telephone:
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Email:
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r_varthani@yahoo.com |
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Affiliation:
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Lecturer |
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Name:
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Dr. Mrs. Sugandhika Suresh
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Address:
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Department of Biochemistry
Faculty of Medical Sciences
Sri Jayewardenepura University, Sri Lanka
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Telephone:
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Tel: 0112758594 |
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Email:
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malalavidhane@yahoo.com |
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Affiliation:
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Senior Lecturer |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age group of 18-60 years at the time of enrollment, of either sex
2. No diagnosed chronic disorders such as hypertension, diabetes mellitus, hypercholesterolaemia, chronic arthritis
3. No history of drug allergy (Ayurvedic or Western).
Exclusion criteria: 1. Use of Those who are receiving any other anti- inflammatory drugs.
2. Pregnancy
3. Breast feeding
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Chronic arthritis (proposed indication)
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Intervention(s)
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The seven constituents of Rasna Sapthakaya decoction are;
1. Alpinia calcarata - root
2. Tinospora cordifolia- stem
3. Cassia fistula- bark of the root
4. Boerhavia diffusa- root
5. Cedrus deodara – wood
6. Ricinus communis - root
7. Tribulus testretris- whole plant/root.
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.
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Primary Outcome(s)
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Serum Alanine transferase (ALT)
[At baseline, Day 8 and Day 15]
Serum Aspartate transferase (AST) [At baseline, Day 8 and Day 15 ]
Serum Alkaline phosphatase (ALP) [At baseline, Day 8 and Day 15 ]
Serum creatinine [At baseline, Day 8 and Day 15 ]
Blood urea [At baseline, Day 8 and Day 15 ]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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University Grants Commission (Grant number UGC/ICD/RG/02/2012/05)
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Ethics review
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Status: Approved
Approval date: 24/06/2014
Contact:
erc.fms.usjp@gmail.com
Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura
+94-112758000 (Extension: 4075)
erc.fms.usjp@gmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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