Safety/toxicity evaluation of a new Ayurveda drug formulation Sudarshana Suspension

• Register: SLCTR
• Last refreshed on: 29 April 2024
• Main ID: SLCTR/2015/005
• Date of registration: 2015-03-02
• Prospective Registration: Yes
• Primary sponsor: HETC Project, Ministry of Higher Education
• Public title: Safety/toxicity evaluation of a new Ayurveda drug formulation Sudarshana Suspension
• Scientific title: A phase I study of the safety/ possible toxicity of a novel Ayurvedic preparation, Sudarshana Suspension.
• Date of first enrolment: 2015-03-02
• Target sample size: 35 (Statistically determined)
• Recruitment status: Complete: follow up complete
• URL: https://slctr.lk/trials/slctr-2015-005
• Study type: Interventional
• Study design: Single arm study
• Phase: Phase 1

Countries of recruitment

Sri Lanka

Contacts

• Name: Dr. W.A.S.S.Weerakoon
• Affiliation: Lecturer and Consultant Ayurvedic Paediatrician

• Name: Dr. T.S.Suresh
• Affiliation: Senior Lecturer Grade I

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Fever (proposed indication)

Intervention(s)

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.

Primary Outcome(s)

Changes in the following bio-markers

1. Alanine aminotransferase (ALT)

2. Aspartate aminotransferase (AST)

3. Gamma-glutamyl transferase (Gamma-GT)

4. Alkaline phosphatase

5. Haemoglobin (Hb)

6. Urea in serum

7. Serum Creatinine


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)

After successive intervention of phase I , phase II studies will be planned according to ERC approval. [At baseline, day 3 and day 8]

Source(s) of Monetary Support

HETC project ,Ministry of Higher Education– CMB/IIM/N4

Ethics review

Status: Approved
Approval date: 22/01/2015
Contact:

[e-mail]

Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura

[phone] (Extension: 4075)

[e-mail]