Effect of a herbal preparation of Coccinia grandis (Ivy gourd, Sin: Kowakka, Tam: Kovakkai) on metabolic markers in patients with type 2 diabetes

Phase 2

Recruiting

• Conditions: Type 2 diabetes mellitus

• Registration Number: SLCTR/2018/012
• Lead Sponsor: ational Research Council, Sri Lanka

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1. Adults of either sex aged between 30 - 60 years
2. Newly diagnosed with type 2 diabetes mellitus
3. Fasting plasma glucose concentration of 126 mg/dL (7.0 mmol/L)-160 mg/dL (8.9 mmol/L) and/or the percentage of glycated haemoglobin of 6.3 – 7.5%
4. Able to communicate effectively with the study personnel
5. Able to be informed of the nature of the study and willing to give written informed consent

Exclusion Criteria

1. Subjects who are on any type of antihyperlipidaemic or antihypertensive therapy which can influence glycaemic control (statins, thiazides respectively)
2. History of hypersensitivity or idiosyncratic reaction to any drugs or herbal products
3. Any disease or condition which may compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system
4. History of allergic conditions
5. History or presence of gastric ulcer or duodenal ulcer
6. History of autoimmune disorders
7. History of psychiatric disorders
8. Intake of herbal products/ supplements/ home decoctions within 14 days prior to the commencement of the study
9. Intake of any long term medication (steroids, thyroxin, nutritional supplements, weight reducing agents etc.) which has effects on hyperglycaemia, dyslipidaemia, hypertension etc
10. Scheduled to undergo hospitalization for surgery during the study period
11. Presence of clinically significant abnormal laboratory results in liver function tests (ALT > x3 times of the upper limit) and renal function tests (eGFR< 90 mL/min/1.72m2) during screening
12. Pregnancy or breastfeeding
13. Use of any recreational drugs or a history of drug addiction
14. Participation in a clinical study of any investigational product one month prior to the first visit or during the study
15. Severe hyperglycaemia (above 300 mg/dL) or infection at the time of diagnosis of T2DM
16. Any other medical condition considered unsuitable for enrolment by a consultant physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the herbal capsule of <i>C. grandis</i> on reducing blood glucose: as determined by serum concentrations of fasting glucose, fructosamine, insulin, HbA1c [At baseline, end of the second week, fourth week, eighth week, twelfth week (insulin, HbA1c at once) from the commencement of intervention]<br> Toxicity/adverse effects of the drug: as determined by serum concentration of gamma glutamyl transferase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, full blood count (FBC) [ At baseline, end of the second week, fourth week, eighth week, twelfth week from the commencement of intervention<br>]<br>

Secondary Outcome Measures

Name	Time	Method
Effect of the herbal capsule of <i>C. grandis </i>on oxidative stress: as determined by malonaldehyde (MDA), Glutathione peroxidase(GPx), Glutathione reductase (GR), Glutathione S-transferase, Reduced glutathione (GSH), <br><br> [ At baseline, and the end of the twelfth week from the commencement of intervention ]<br> Effect of the herbal capsule of <i>C. grandis</i> on inflammation: as determined by high sensitivity C-reactive protein(hsCRP), interleukin-6(IL-6), tumor necrosis factor-alpha (TNF- a) [ At baseline, and the end of twelfth week from the commencement of intervention]<br>