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

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

first given placebo biscuit for three months and after wash out period of one month given Kothala Himbutu biscuit (extract of Salacia reticulata) for three moths

Placebo Biscuit First Then Kothala Himbutu Biscuit Group

first given Kothala Himbutu biscuit (extract of Salacia reticulata) for three months and after wash out period of one month given placebo biscuit for three moths

Kothala Himbutu First Then Placebo Biscuit Group

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Blood samples were analyzed at a centrally accredited lab and HBA1c was measured using ion exchange high performance liquid chromatography standardized to NGSP

Glycosylated Haemoglobin

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

first given placebo biscuit for three months and after wash out period of one month given Kothala Himbutu biscuit (extract of Salacia reticulata) for three moths.

Kothala Himbutu Biscuit First Then Placebo Biscuit Group

liver functions are described in the table below with higher liver enzymes suggesting injury to the liver.

Kothala Himbutu Biscuit First and the Placebo Biscuit Group

Liver Adverse Effects

Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney.

Renal Adverse Effects -1

Renal functions are described in the table below with higher serum creatinine suggesting injury to the kidney.

Renal Adverse Effects - 2

(Description of the placebo biscuit, and the Kothala Himbutu biscuit is described in the other arm)) An identical placebo biscuit without the herbal extract from Kothala Himbutu (Salacia reticulate). Given as same as the Kothala Himbutu biscuit and manufactured by the same manufacturer.

Placebo Biscuit First and Then Kothala Himbutu Biscuit

A biscuit containing Kothala Himbutu (Salacia reticulata) extract. This biscuit is available in the supermarkets. Four biscuits twice a day as a mid morning and a mid afternoon snack for 3 months. Dry bark of the Salacia reticulate plant (210kg) is boiled repeatedly with water and evaporated to 210 liters of extract containing 10.5kg of dried extract (Herbal drug to extract ratio 1:1). The 100g of biscuit mixture are blended with 1.042ml of the aqueous extract. The raw material was authenticated by thin layer chromatography finger print analysis by the Industrial Technology Institute, Colombo. The energy, carbohydrate and fiber content of the study and the placebo biscuits are identical. The KH biscuit contained 447.21kcal of energy, 10.42g of protein, 13.97g of fat (6.29g saturated), 69.95g of carbohydrates (less than 0.10g of sugar), 7.53g of dietary fiber and 979mg of sodium per 100g. Glycaemic index of the KH biscuit was 30 and the placebo biscuit was 56.

Kothala Himbutu Biscuit First and Then Placebo Biscuit

First Period of Three Months

Second Period of 3 Months

Professor Sisira Siribaddana

Adverse events are reported "per intervention" (participants consuming placebo biscuits are presented here). Separate Arms/Groups reflect all participants who received each intervention during the study.

Placebo Biscuit Group

Adverse events are reported "per intervention" (participants consuming Kothala Himbutu biscuits are presented here). Separate Arms/Groups reflect all participants who received each intervention during the study.

Kothala Himbutu Biscuit Group

Type 2 Diabetes Mellitus

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

Kothala Himbutu Biscuit

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

Placebo Biscuit

Teaching Hospital Anuradhapura

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

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

Individual Patient Data (IPD) will be available for researchers.

Rajarata University, Sri Lanka

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.

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.

kothala/diabetes mellitus

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

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