The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study

NCT02290925 | Completed Phase 3 Results DMC

• 1 other identifier: RAJ-001
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

biscuit containing Salacia reticulate; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Glycosylated Haemoglobin

  HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP

  After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)

Secondary Outcomes (3)

• Liver Adverse Effects

  Baseline, after 3 months, and after 7 months

• Renal Adverse Effects -1

  baseline, after 3 months and after 7 months

• Renal Adverse Effects - 2

  Baseline, after 3 months, and after 7 months

Study Arms (2)

Kothala Himbutu biscuit

EXPERIMENTAL

A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day for 3 months.

Drug: Kothala Himbutu Biscuit

placebo biscuit

PLACEBO COMPARATOR

An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate)

Dietary Supplement: Placebo Biscuit

Interventions

Kothala Himbutu Biscuit DRUG

Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.

Also known as: Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuit

Kothala Himbutu biscuit

Placebo Biscuit DIETARY_SUPPLEMENT

Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)

Also known as: Biscuit, Munchee biscuit

placebo biscuit

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes for minimum period of 6 months
• Aged between 30 and 65 years
• Stable glycaemic control over the preceding 2-3 months. They will be initially selected from a range of HBA1C varying from 6.5 - 14 and the individual subject should not have a variation of \>20% between the previous HBA1C and the HBA1C done at the commencement of the study

You may not qualify if:

• Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour
• Severe valvular heart disease or heart failure.
• Those on Insulin therapy
• Severe liver disease (AST \> 10 X times the upper limit)

Sponsors & Collaborators

• Rajarata University, Sri Lanka: lead

Study Sites (1)

Teaching Hospital Anuradhapura

Anuradhapura, North Central Province, 50000, Sri Lanka

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

BAG 0177

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Withdrawing patients needing insulin from the trial compromised the pragmatic nature of the RCT. Blinding of the patients may have been affected because of the slightly different taste and darker nature of the KH biscuit.

Results Point of Contact

• Title: Professor Sisira Siribaddana
• Organization: Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka

sisira.siribaddana@gmail.com

+94777326940

Study Officials

• Nadeesha Wickramasinghe, BSc

  Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization code (A or B) was made using a computer and inserted in a sealed, serially numbered, opaque envelopes. Participants were given a serial number after run-in period. Assistant opened the envelope and assigned the patient to either biscuit A or B. The manufacturers held randomization code. Investigators, patients and those assessing the analysis were masked to the group outcome. Both Kothala Himbutu (KH) and placebo biscuits are identical in size, wrapped in same cover, and packed in identical boxes. The investigators tasted both biscuits and KH biscuits were slightly darker with the same taste. The study product is available in the market. Patients participating in the trial were asked about prior consumption of KH biscuits bought from the market (to exclude contamination). At the end of each period patients were asked whether they could assume the type of biscuit (KH biscuit or placebo) given to them and their preference for the type.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with diabetes were screened and Type I Diabetes was excluded. The minimum run-in period was eight weeks and if the variability of HbA1c is more than 20%, excluded, to exclude patients with fluctuating glycaemia. As this is a crossover trial some degree of stability of the glycemic control is necessary to prevent excessive variation of HbA1c interfering with the study outcome. Participants were randomized to receive the KH or placebo biscuit. Oral hypoglycemic was continued and adjusted. Participants consumed KH or placebo biscuit for a period of 3 months as mid-morning and afternoon snack. Subsequently in the washout period of 1 month the participants did not consumed any biscuits. After, crossing over they continued biscuits for another 3 months. HbA1c was done at recruitment, after run-in period, at 3 months and on completion of the study. When there was deterioration of the glycaemic control patient was prescribed insulin, and withdrawn from the study.

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 14, 2019
• Results First Posted: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 10 years after end of the study (March 2019)
• Access Criteria: Any qualified researcher should submit the protocol and get the ERC clearence from institutional IRB (Ethics Review Committee, Faculty of Medicine \& Allied Science, Rajarata University of Sri Lanka). After that they need to come to an written agreement with the researchers to analyze the data.

Locations

SR (1)