Who is sponsoring NCT02290925?

NCT02290925 is sponsored by Rajarata University, Sri Lanka.

What drugs are being tested in NCT02290925?

Interventions in NCT02290925: Kothala Himbutu Biscuit, Placebo Biscuit.

What condition does NCT02290925 study?

NCT02290925 studies Type 2 Diabetes Mellitus.

Is NCT02290925 still recruiting?

NCT02290925 is currently completed. Last updated 2 May 2019.

Are results published for NCT02290925?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-05-02 · How we verify

NCT02290925

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Effect of a Biscuit Containing the Extract of Salacia Reticulata on Glycaemia in Patients With Type 2 Diabetes Mellitus Randomized Triple Blind Placebo Controlled Two Period Two Sequence Crossover Clinical Trial

Completed Phase 3 Results posted Last updated 2 May 2019

What this trial tests

Phase 3 trial testing Kothala Himbutu Biscuit in Type 2 Diabetes Mellitus in 133 participants. Completed in 1 April 2017.

Timeline

1 May 2014

Primary endpoint
1 April 2017

1 April 2017

Quick facts

Lead sponsor	Rajarata University, Sri Lanka
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	133
Start date	1 May 2014
Primary completion	1 April 2017
Estimated completion	1 April 2017
Sites	1 location across Sri Lanka

Drugs / interventions tested

Kothala Himbutu Biscuit — full drug profile →
Placebo Biscuit

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Rajarata University, Sri Lanka

Who can join

Adults 30 to 65, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Glycosylated Haemoglobin
Time frame: After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)
HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP

Sponsor's own description

The investigators intend to conduct a triple blind randomized clinical trial to investigate the effect of a biscuit containing herbal extract, available in the market on the fasting blood sugar control in patients with diabetes mellitus and also to find out whether there are any side effects on other vital organs such as kidneys and liver.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Natural Products to Counteract the Epidemic of Cardiovascular and Metabolic Disorders.
Waltenberger B, Mocan A, Šmejkal K, Heiss EH, et al · · 2016 · cited 103× · PMID 27338339 · DOI 10.3390/molecules21060807
The Effect of Salacia Reticulata Extract Biscuits on Blood Sugar Control of Type 2 Diabetes Mellitus Patients: A Two-Period, Two-Sequence, Crossover, Randomized, Triple-Blind, Placebo-Controlled, Clinical Trial.
Siribaddana S, Medagama A, Wickramasinghe N, Siribaddana NM, et al · · 2023 · PMID 37885536 · DOI 10.7759/cureus.45921

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02290925 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rajarata University, Sri Lanka
Last refreshed: 2 May 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02290925.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing