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Effect of a standardized herbal capsule of Coccinia grandis (L.) Voigt on selected metabolic parameters in patients with type 2 diabetes mellitus: A Randomized Controlled Trial -

SLCTR Registration Number

SLCTR/2018/012


Date of Registration

17 Apr 2018

The date of last modification

Apr 17, 2018



Application Summary


Scientific Title of Trial

Effect of a standardized herbal capsule of Coccinia grandis (L.) Voigt on selected metabolic parameters in patients with type 2 diabetes mellitus: A Randomized Controlled Trial


Public Title of Trial

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


Disease of Health Condition(s) Studied

Type 2 diabetes mellitus


Scientific Acronym

None


Public Acronym

None


Brief title

Effect of a herbal drug on metabolic profile in diabetic patients


Universal Trial Number

U1111-1207-6305


Any other number(s) assigned to the trial and issuing authority

14.06.2017:3.9 (ERC, Ruhuna)


Trial Details


What is the research question being addressed?

What is the effect of a herbal capsule of Coccinia grandis on selected metabolic markers in patients with newly diagnosed type 2 diabetes mellitus?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Purpose

Phase 2


Intervention(s) planned

Study subjects meeting inclusion and exclusion criteria attending the university medical clinics, Teaching Hospital, Karapitiya will be recruited for the study. Participants will be randomly allocated to either to the intervention arm (herbal drug) or the control arm (placebo) using random number tables.

Interventional product: freeze dried powder of the aqueous refluxed extract of C. grandis in oral gelatin capsules.

Placebo: corn starch in identical oral gelatin capsules

Intervention arm: participants will receive 500mg of the herbal capsule (1 capsule) to be taken twice a day for a total of 3 months.

Placebo arm: participants will receive matching placebo capsules to be taken (1 capsule) twice a day for a total of 3 months.

All participants will receive standard management, including non-pharmacological interventions in accordance with the guidelines of the Sri Lanka College of Endocrinologists and the American Diabetes Association. Patients will be strictly advised to refrain from taking additional herbal supplementation/ neutraceutical products/home- made recipes/ herbal decoctions for the stipulated intervention period.

Study participants and data collectors/analysts will be blinded to the intervention


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


Primary outcome(s)

Outcome1: Efficacy of the herbal capsule of C. grandis on reducing blood glucose: as determined by serum concentrations of fasting glucose, fructosamine, insulin, HbA1c

Outcome 2: 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)


Primary outcome(s) - Time of assessment(s)

Outcome 1: At baseline, end of the second week, fourth week, eighth week, twelfth week (insulin, HbA1c at once) from the commencement of intervention

Outcome 2: At baseline, end of the second week, fourth week, eighth week, twelfth week from the commencement of intervention


Secondary outcome

Outcome 1: Effect of the herbal capsule of C. grandis on oxidative stress: as determined by malonaldehyde (MDA), Glutathione peroxidase(GPx), Glutathione reductase (GR), Glutathione S-transferase, Reduced glutathione (GSH),

Outcome 2: Effect of the herbal capsule of C. grandis on inflammation: as determined by high sensitivity C-reactive protein(hsCRP), interleukin-6(IL-6), tumor necrosis factor-alpha (TNF- α)


Secondary outcome(s) - Time of assessment(s)

Outcome 1: At baseline, and the end of the twelfth week from the commencement of intervention

Outcome 2: At baseline, and the end of twelfth week from the commencement of intervention



Target number/sample size

82 (41 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-07-01


Anticipated end date

2020-04-01


Recruitment status

Pending


State of ethics review approval

Approved by the ERC, Faculty of Medicine, University of Ruhuna on 10th January 2018 (Ref: 14.06.2017:3.9)


Funding source

National Research Council, Sri Lanka (Grant no: 17-029)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr A.P. Attanayake
Senior Lecturer in Biochemistry
Department of Biochemistry, Faculty of Medicine, University of Ruhuna, Karapitiya, Galle.
Tel: 091 2234801
Mob: 0714428121
Fax: 0912222314
anoja715@yahoo.com
http://www.medi.ruh.ac.lk/index.php/biochemistry-staff-members

Contact Person for Public Queries

Dr A.P. Attanayake
Senior Lecturer in Biochemistry
Department of Biochemistry, Faculty of Medicine, University of Ruhuna, Karapitiya, Galle.
Tel: 091 2234801
Mob: 0714428121
Fax: 0912222314
anoja715@yahoo.com
http://www.medi.ruh.ac.lk/index.php/biochemistry-staff-members


Primary study sponsor/organization

National Research Council, Sri Lanka

Ground Floor, Sri Lanka Institute of Architects Building, 120/07, Vidya Mawatha Colombo 07, Sri Lanka
+ Tel: +94 011 2675176; +94 011 2675430
Fax: +94 11 2675136

http://www.nrc.gov.lk/

Secondary study sponsor (If any)

None