Type 2 Diabetes MellitusPhase 3NCT02290925

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

A Phase 3 study testing Kothala Himbutu Biscuit in people with Type 2 Diabetes Mellitus, run by Rajarata University, Sri Lanka at 1 site in Sri Lanka.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Kothala Himbutu Biscuit
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 1 siteSri Lanka
Study dates: May 2014to Apr 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Sri Lanka1 site

Teaching Hospital Anuradhapura
Anuradhapura, North Central Province, 50000

Other trials in Sri Lanka

About this study

Official title: 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

Read the detailed description

The effect of a biscuit containing the extract of Salacia reticulata (Kothala Himbutu) on the reduction of blood glucose levels in patients with Type 2 Diabetes Mellitus. A single center randomized triple blind placebo controlled two period two sequence crossover clinical trial.

Conditions: Type 2 Diabetes Mellitus
Being tested: Kothala Himbutu Biscuit, Placebo Biscuit
Keywords: biscuit containing Salacia reticulate, randomised controlled trial
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kothala Himbutu BiscuitDrug
Also called Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuit
Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.
Placebo BiscuitDietary supplement
Also called Biscuit, Munchee biscuit
Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)

Study groups in NCT02290925
Study group	Role	What they receive
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. Receives: Drug: Kothala Himbutu Biscuit
placebo biscuit	Placebo comparator	An identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate) Receives: Dietary Supplement: Placebo Biscuit

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycosylated Haemoglobin
HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP
Measured: 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
liver functions are described in the table below with higher liver enzymes suggesting injury to the liver.
Measured: Baseline, after 3 months, and after 7 months
Renal Adverse Effects -1
Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney.
Measured: baseline, after 3 months and after 7 months
Renal Adverse Effects - 2
Renal functions are described in the table below with higher serum creatinine suggesting injury to the kidney.
Measured: Baseline, after 3 months, and after 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Apr 2017

First posted14 Nov 2014 (estimated)
Study startMay 2014
Primary completionApr 2017
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02290925
Sponsor's protocol ID: RAJ-001
Status last verified: Mar 2019
First submitted: 7 Nov 2014
Last updated: 14 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Individual Patient Data (IPD) will be available for researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02290925
Acronym / sponsor ID: RAJ-001
Conditions: Type 2 Diabetes Mellitus
Keywords: biscuit containing Salacia reticulate, randomised controlled trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Rajarata University, Sri LankaUniversity, hospital or other
Study start: May 2014
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 14 Nov 2014 (estimated)
Results: Posted 27 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Kothala Himbutu biscuit	Experimental	Drug: Kothala Himbutu BiscuitA biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day for 3 months.
placebo biscuit	Placebo comparator	Dietary Supplement: Placebo BiscuitAn identical biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate)

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Kothala Himbutu BiscuitAlso: Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuitKothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.	Drug	Kothala Himbutu biscuit
Placebo BiscuitAlso: Biscuit, Munchee biscuitPlacebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)	Dietary supplement	placebo biscuit

Primary outcome

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

3 secondary outcomes

Liver Adverse Effects
Time frame: Baseline, after 3 months, and after 7 months
Renal Adverse Effects -1
Time frame: baseline, after 3 months and after 7 months
Renal Adverse Effects - 2
Time frame: Baseline, after 3 months, and after 7 months

Results and safety

Results posted to the registry on 27 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Biscuit First and Then Kothala Himbutu Biscuit	62	58
Kothala Himbutu Biscuit First and Then Placebo Biscuit	71	69

Primary outcome: 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). Mean (Standard Error). Unit: percentage of glycosylated hemoglobin

Measure	Placebo Biscuit First Then Kothala Himbutu Biscuit Group n = 62	Kothala Himbutu Biscuit First Then Placebo Biscuit Group n = 71
After period 1(3 months)	8.36 (0.19)	8.16 (0.20)
After period 2 (trial end-7 months)	8.23 (0.21)	8.53 (0.21)

Placebo Biscuit First Then Kothala Himbutu Biscuit Group vs Kothala Himbutu Biscuit First Then Placebo Biscuit Group: Mean Difference (Net): 0.25

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: seven months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Biscuit Group	1 of 131 (0.8%)	0 of 131 (0%)	1 of 131
Kothala Himbutu Biscuit Group	0 of 129 (0%)	0 of 129 (0%)	0 of 129

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual Patient Data (IPD) will be available for researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nadeesha Wickramasinghe, BSc study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Kothala Himbutu Biscuit in people with Type 2 Diabetes Mellitus, run by Rajarata University, Sri Lanka at 1 site in Sri Lanka.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02290925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.