Slctr

A Phase IIIb/lV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to compare the efficacy and safety of Thriphala® with placebo in patients with constipation associated with Irritable Bowel Syndrome (IBS-C)

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SLCTR Registration Number

SLCTR/2013/032

Date of Registration

08 Oct 2013

The date of last modification

Mar 03, 2019

Trial Status

Application Summary

Scientific Title of Trial

A Phase IIIb/lV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to compare the efficacy and safety of Thriphala® with placebo in patients with constipation associated with Irritable Bowel Syndrome (IBS-C)

Public Title of Trial

Usefulness of Thriphala in constipation associated with Irritable Bowel Syndrome

Disease or Health Condition(s) Studied

Constipation associated with Irritable Bowel Syndrome

Scientific Acronym

TESIBSC (Thriphala®; Efficacy and Safety in Irritable Bowel Syndrome with Constipation)

Public Acronym

None

Brief title

None

Universal Trial Number

U1111-1147-1846

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

P104/06/2013 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)

Trial Details

What is the research question being addressed?

What is the efficacy and safety of Thriphala® compared to placebo in the relief of constipation associated with IBS?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded

Control

Placebo

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 3

Intervention(s) planned

Participants will be randomized into two arms. The intervention arm will receive the active agent (Thriphala®) to be taken orally, 1-2 tablets at night (depending on the level of symptoms), for a period of 56 days.

The control arm will receive a placebo (with no active ingredients included) to be taken in the same manner for 56 days.

Inclusion criteria

Patients with diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis
Male and females aged 18 to 80 years
Females of child-bearing potential who consent to employ an adequate method of contraception and undergo a pregnancy test at Randomisation Visit
Willingness and competency to complete the entire study and comply with study instructions.
Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.
Less than 3 spontaneous bowel movements during the last 7 days of the run-in period

Exclusion criteria

History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, complicated diverticulitis, ulcerative colitis, toxic megacolon and occlusive or subocclusive syndrome.
Abdominal pain of unknown cause, not related to IBS.
Previous major abdominal surgery.
IBS subtypes other than IBS-C (symptoms of IBS-diarrhoea (IBS-D) or IBS-mixed (IBS-M)
Known hypersensitivity to any of the active substances.
Laxative, drug or alcohol abuse (recent history or within previous 12 months)
Pregnant or lactating females.
Severe or acute disease within 2 weeks prior to the start of the study.
Type I or II diabetes
Use of other investigational drug s, prescribed or OTC medications affecting gastrointestinal function (anticholinergics, prokinetics, drugs affecting motility, anthraquinones. opioids,ondansetron or other 5-HT3 antagonists).
Incomplete Patient Diary Card during the run-in period.
Occurrence of diarrhoea during the run-in period.
Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT requiring further investigation.
Any condition, which, in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the results of the study.

Primary outcome(s)

Mean number of spontaneous bowel movements

[
Measured in the 7-day period prior to completion of 56 days of treatment
]

Secondary outcome(s)

1. Effect of treatment on other symptoms of IBS (abdominal pain, abdominal bloating, straining and feeling of incomplete evacuation)	[ During the 14th, 28th, 49th, 56th days follwing initiation of the study ]
2. Effect of treatment on patient's Quality of Life (using a standard questionnaire – IBS-QOL)	[ During the 14th, 28th, 49th, 56th days follwing initiation of the study ]
3. To evaluate the safety of treatment (using a predetermined questionnaire, assessing specific adverse effects of Thriphala®)	[ During the 14th, 28th, 49th, 56th days follwing initiation of the study ]
4. To evaluate incidence of adverse events	[ During the 14th, 28th, 49th, 56th days follwing initiation of the study ]
5. To evaluate compliance (using a pill count)	[ During the 14th, 28th, 49th, 56th days follwing initiation of the study ]
6. To evaluate the use of rescue medication	[ During the 14th, 28th, 49th, 56th days follwing initiation of the study ]

Target number/sample size

200

Countries of recruitment

Sri Lanka

Anticipated start date

2013-10-08

Anticipated end date

2014-09-10

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

Link Natural Products (PVT) Ltd

Regulatory approvals

State of Ethics Review Approval

Status

Approved

Date of Approval

2013-06-12

Approval number

P104/06/2013

Details of Ethics Review Committee

Name:	Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:	PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:	+94-11-2961267
Email:	erckelaniya@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr Madunil A Niriella
Senior Lecturer and Consultant Gastroenterologist
Department of Medicine,Faculty of Medicine, PO Box 6, Thalagolla Rd, Ragama
0112953409
0714820948
0112958337
maduniln@yahoo.co.uk

Contact Person for Public Queries

Primary study sponsor/organization

Link Natural Products (PVT) Ltd

Link Natural Products (PVT) Ltd, Factory and Sales Office, Malinda, Kapugoda
0112409294
0112409293

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

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results

Trial Options

A Phase IIIb/lV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to compare the efficacy and safety of Thriphala® with placebo in patients with constipation associated with Irritable Bowel Syndrome (IBS-C) -

Application Summary

Trial Details

State of Ethics Review Approval

Contact & Sponsor Information

Trial Completion details

A Phase IIIb/lV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to compare the efficacy and safety of Thriphala® with placebo in patients with constipation associated with Irritable Bowel Syndrome (IBS-C)

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