Trial | NCT02290925  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Intervention/Treatment

    kothala himbutu ...

  • Study Participants

    133
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.
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.
Study Started
May 31
2014
Primary Completion
Apr 30
2017
Study Completion
Apr 30
2017
Results Posted
Mar 27
2019
Last Update
May 14
2019

Drug 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.

  • Other names: Biscuit contining Salacia reticulata extract, Kothala Himbutu Biscuit manufactured by Ceylon Biscuits Ltd, Munchee Kothala Himbutu biscuit

Dietary Supplement Placebo Biscuit

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

  • Other names: Biscuit, Munchee biscuit

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.

placebo biscuit Placebo Comparator

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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)

Summary

Placebo Biscuit Group

Kothala Himbutu Biscuit Group

All Events

Event Type Organ System Event Term Placebo Biscuit Group Kothala Himbutu Biscuit Group

Glycosylated Haemoglobin

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

Placebo Biscuit First Then Kothala Himbutu Biscuit Group

After period 1(3 months)

8.36
percentage of glycosylated hemoglobin (Mean)
Standard Error: 0.19

After period 2 (trial end-7 months)

8.23
percentage of glycosylated hemoglobin (Mean)
Standard Error: 0.21

Kothala Himbutu Biscuit First Then Placebo Biscuit Group

After period 1(3 months)

8.16
percentage of glycosylated hemoglobin (Mean)
Standard Error: 0.20

After period 2 (trial end-7 months)

8.53
percentage of glycosylated hemoglobin (Mean)
Standard Error: 0.21

Liver Adverse Effects

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

Placebo Biscuit First Then Kothala Himbutu Biscuit Group

ALT (IU/L) after 3 months

39.0
International Units per Liter (Mean)
Full Range: 12.0 to 124.0

ALT (IU/L) after 7 months

37.0
International Units per Liter (Mean)
Full Range: 11.0 to 110.0

ALT (IU/L) at baseline

38.0
International Units per Liter (Mean)
Full Range: 12.0 to 95.0

AST (IU/L) after 3 months

28.0
International Units per Liter (Mean)
Full Range: 11.0 to 132.0

AST (IU/L) after 7 months

27.0
International Units per Liter (Mean)
Full Range: 12.0 to 90.0

AST (IU/L) at baseline

28.0
International Units per Liter (Mean)
Full Range: 11.0 to 97.0

Kothala Himbutu Biscuit First and the Placebo Biscuit Group

ALT (IU/L) after 3 months

36.0
International Units per Liter (Mean)
Full Range: 11.0 to 111.0

ALT (IU/L) after 7 months

34.0
International Units per Liter (Mean)
Full Range: 12.0 to 90.0

ALT (IU/L) at baseline

37.0
International Units per Liter (Mean)
Full Range: 9.0 to 129.0

AST (IU/L) after 3 months

26.0
International Units per Liter (Mean)
Full Range: 10.0 to 73.0

AST (IU/L) after 7 months

24.0
International Units per Liter (Mean)
Full Range: 10.0 to 55.0

AST (IU/L) at baseline

28.0
International Units per Liter (Mean)
Full Range: 11.0 to 111.0

Renal Adverse Effects -1

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

Placebo Biscuit First Then Kothala Himbutu Biscuit Group

eGFR (ml/min/1.73m^2) after 3 months

75.0
milliliters/minute/1.73m^2 (Mean)
Full Range: 39.0 to 90.0

eGFR (ml/min/1.73m^2) after 7 months

75.0
milliliters/minute/1.73m^2 (Mean)
Full Range: 41.0 to 90.0

eGFR (ml/min/1.73m^2) at baseline

77.1
milliliters/minute/1.73m^2 (Mean)
Full Range: 41.0 to 90.0

Kothala Himbutu Biscuit First Then Placebo Biscuit Group

eGFR (ml/min/1.73m^2) after 3 months

75.0
milliliters/minute/1.73m^2 (Mean)
Full Range: 41.0 to 90.0

eGFR (ml/min/1.73m^2) after 7 months

76.0
milliliters/minute/1.73m^2 (Mean)
Full Range: 41.0 to 90.0

eGFR (ml/min/1.73m^2) at baseline

76.0
milliliters/minute/1.73m^2 (Mean)
Full Range: 41.0 to 90.0

Renal Adverse Effects - 2

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

Placebo Biscuit First Then Kothala Himbutu Biscuit Group

Serum creatinine (mg/dL) after 3 months

0.98
milligrams per deciliter (Mean)
Full Range: 0.7 to 1.97

Serum creatinine (mg/dL) after 7 months

0.97
milligrams per deciliter (Mean)
Full Range: 0.6 to 1.8

Serum creatinine (mg/dL) at baseline

0.94
milligrams per deciliter (Mean)
Full Range: 0.04 to 1.84

Kothala Himbutu Biscuit First Then Placebo Biscuit Group

Serum creatinine (mg/dL) after 3 months

0.96
milligrams per deciliter (Mean)
Full Range: 0.62 to 1.7

Serum creatinine (mg/dL) after 7 months

0.93
milligrams per deciliter (Mean)
Full Range: 0.61 to 1.39

Serum creatinine (mg/dL) at baseline

0.94
milligrams per deciliter (Mean)
Full Range: 0.1 to 1.47

Total

133
Participants

Age, Continuous

50.5
years (Mean)
Standard Deviation: 7.7

Glycosylated Haemoglobin

8.56
percentage of glycosylated haemoglobin (Mean)
Standard Deviation: 1.42

Age, Categorical

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

First Period of Three Months

Placebo Biscuit First and Then Kothala Himbutu Biscuit

Kothala Himbutu Biscuit First and Then Placebo Biscuit

Second Period of 3 Months

Placebo Biscuit First and Then Kothala Himbutu Biscuit

Kothala Himbutu Biscuit First and Then Placebo Biscuit

Drop/Withdrawal Reasons

Placebo Biscuit First and Then Kothala Himbutu Biscuit

Kothala Himbutu Biscuit First and Then Placebo Biscuit