The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Kothala Himbutu Biscuit; Placebo Biscuit
Intervention description: Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.; Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 When there was deterioration of the glycaemic control patient was prescribed insulin, and withdrawn from the study.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 133.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: biscuit containing Salacia reticulate; randomised controlled 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 as kidneys and liver.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type 2 diabetes for minimum period of 6 months

          2. Aged between 30 and 65 years

          3. 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

        Exclusion Criteria:

          1. Chronic kidney disease with estimated Glomerular filtration rate less than 30ml/hour

          2. Severe valvular heart disease or heart failure.

          3. Those on Insulin therapy

          4. Severe liver disease (AST > 10 X times the upper limit)