Home » Trials » SLCTR/2015/019


Phase II clinical trial - the effects of extract of Costus speciosus (thebu) on hepatic insulin resistance and biochemical profile of patients with nonalcoholic fatty liver disease.

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SLCTR Registration Number

SLCTR/2015/019


Date of Registration

15 Sep 2015

The date of last modification

Apr 30, 2019



Application Summary


Scientific Title of Trial

Phase II clinical trial - the effects of extract of Costus speciosus (thebu) on hepatic insulin resistance and biochemical profile of patients with nonalcoholic fatty liver disease.


Public Title of Trial

Effects of thebu leaves on fatty liver - phase 2 clinical trial


Disease or Health Condition(s) Studied

Non-alcoholic fatty liver disease


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

None


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

ERC Ruhuna Ref: 02/07/2015: 3.1


Trial Details


What is the research question being addressed?

What is the human efficacy and safety of a newly formulated capsule containing Costus speciosus (thebu) leaf extract on liver enzymes and insulin resistance in patients with Non-alcoholic fatty liver disease (NAFLD)?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 2


Intervention(s) planned

The study will be carried out at the Department of Pharmacology Faculty of Medicine University of Ruhuna with ultra sound scanning done at Teaching Hospital Karapitiya.

Consenting participants meeting inclusion/exclusion criteria will be allocated into two arms using block randomization. The two arms will be randomly selected to receive either the intervention or the control. All participants will be exposed to a special dietary management plan by a dietitian.

The intervention arm will receive 250mg of Costus speciosus (thebu) leaf extract in a capsule form, twice a day for three months

The control arm will receive a matching placebo for the same frequency and duration.


Inclusion criteria

  1. Male and female patients aged 30-65 years
  2. Diagnosis of NAFLD stage 1 and 2 by ultrasound scan by a physician and radiologist

Exclusion criteria

  1. Alcoholism.(consumption of any alcohol within the past 6 weeks)
  2. Current treatment with hepatotoxic drugs.
  3. Hepatitis B infection (positive HBsAg with recent vaccination)
  4. Diabetes mellitus, heart failure, ischaemic heart disease
  5. Autoimmune disorders.
  6. Any type of long term drug treatment for diabetes, dyslipidemia or high blood pressure.


Primary outcome(s)

1.
  1. 30% reduction in insulin resistence (IR) calculated by using HOMA QUICKI and McAuley indices

  2. Sustained reduction in Alanine aminotransferase(ALT) defined as 50% or less of the baseline level or 40U/L or less at clinic visits every 4 weeks.

[

At baseline, then every 4 weeks for a total of 12 weeks.

]

Secondary outcome(s)

1.
  1. Grading of NAFLD on ultra sound scan
  2. Health related quality of life.(QOL)
  3. Anthropometric variables
[

At baseline, then every 4 weeks for a total of 12 weeks.

]

Target number/sample size

64 (32 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2015-10-01


Anticipated end date

2016-01-01


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2015-07-22


Approval number

02/07/2015: 3.1


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 & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof Menik Hettihewa
Professor of Pharmacology
Department of Pharmacology Faculty of Medicine University of Ruhuna Galle Sri Lanka
0094 91 2234801 or 0094 91 22248677
0094 718051252
0094 91 2222314
hettihewamenik@gmail.com
www.med.ruh.ac.lk

Contact Person for Public Queries

Prof Menik Hettihewa
Professor of Pharmacology
Department of Pharmacology Faculty of Medicine University of Ruhuna Galle Sri Lanka
0094 91 2234801 or 0094 91 22248677
0094 718051252
0094 91 2222314
hettihewamenik@gmail.com
www.med.ruh.ac.lk


Primary study sponsor/organization

Faculty of Medicine

University of Ruhuna PO box 70, Karapitiya, Galle, Sri Lanka
Tel: 0094 91 2234801


www.med.ruh.ac.lk

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not available


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