Trial Outcomes & Findings for The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study (NCT NCT02290925)
NCT ID: NCT02290925
Last Updated: 2019-05-14
Results Overview
HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
133 participants
Primary outcome timeframe
After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)
Results posted on
2019-05-14
Participant Flow
All recruitment carried out in medical clinic, Teaching Hospital anuradhapura
Run-in period was 8 weeks and if the variability of the HbA1c is more than 20%, participants were excluded. This was done to exclude patients with fluctuating glycaemia. Wash out for 1 month after 1st period of giving treatment for 3 months. After the wash out patients are crossed over for the other biscuit given for another three months
Participant milestones
| Measure |
Placebo Biscuit First and Then Kothala Himbutu Biscuit
(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.
|
Kothala Himbutu Biscuit First and Then Placebo 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.
|
|---|---|---|
|
First Period of Three Months
STARTED
|
62
|
71
|
|
First Period of Three Months
COMPLETED
|
58
|
69
|
|
First Period of Three Months
NOT COMPLETED
|
4
|
2
|
|
Second Period of 3 Months
STARTED
|
58
|
69
|
|
Second Period of 3 Months
COMPLETED
|
57
|
65
|
|
Second Period of 3 Months
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Placebo Biscuit First and Then Kothala Himbutu Biscuit
(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.
|
Kothala Himbutu Biscuit First and Then Placebo 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.
|
|---|---|---|
|
First Period of Three Months
Lost to Follow-up
|
2
|
1
|
|
First Period of Three Months
Death
|
1
|
0
|
|
First Period of Three Months
Insulin Started
|
1
|
1
|
|
Second Period of 3 Months
Lost to Follow-up
|
1
|
3
|
|
Second Period of 3 Months
insulin started
|
0
|
1
|
Baseline Characteristics
The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
Baseline characteristics by cohort
| Measure |
Placebo Biscuit First Then Kothala Himbutu Biscuit Group
n=62 Participants
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 First Then Placebo Biscuit Group
n=71 Participants
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
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
50.7 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
50.5 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
62 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
133 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Sri Lanka
|
62 participants
n=99 Participants
|
71 participants
n=107 Participants
|
133 participants
n=206 Participants
|
|
Glycosylated Haemoglobin
|
8.45 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.40 • n=99 Participants
|
8.65 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.44 • n=107 Participants
|
8.56 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.42 • n=206 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo Biscuit First Then Kothala Himbutu Biscuit Group
n=62 Participants
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
n=71 Participants
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
|
|---|---|---|
|
Glycosylated Haemoglobin
After period 1(3 months)
|
8.36 percentage of glycosylated hemoglobin
Standard Error 0.19
|
8.16 percentage of glycosylated hemoglobin
Standard Error 0.20
|
|
Glycosylated Haemoglobin
After period 2 (trial end-7 months)
|
8.23 percentage of glycosylated hemoglobin
Standard Error 0.21
|
8.53 percentage of glycosylated hemoglobin
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, after 3 months, and after 7 monthsPopulation: adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis
liver functions are described in the table below with higher liver enzymes suggesting injury to the liver.
Outcome measures
| Measure |
Placebo Biscuit First Then Kothala Himbutu Biscuit Group
n=62 Participants
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
n=71 Participants
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
|
|---|---|---|
|
Liver Adverse Effects
ALT (IU/L) at baseline
|
38 International Units per Liter
Interval 12.0 to 95.0
|
37 International Units per Liter
Interval 9.0 to 129.0
|
|
Liver Adverse Effects
ALT (IU/L) after 3 months
|
39 International Units per Liter
Interval 12.0 to 124.0
|
36 International Units per Liter
Interval 11.0 to 111.0
|
|
Liver Adverse Effects
ALT (IU/L) after 7 months
|
37 International Units per Liter
Interval 11.0 to 110.0
|
34 International Units per Liter
Interval 12.0 to 90.0
|
|
Liver Adverse Effects
AST (IU/L) at baseline
|
28 International Units per Liter
Interval 11.0 to 97.0
|
28 International Units per Liter
Interval 11.0 to 111.0
|
|
Liver Adverse Effects
AST (IU/L) after 3 months
|
28 International Units per Liter
Interval 11.0 to 132.0
|
26 International Units per Liter
Interval 10.0 to 73.0
|
|
Liver Adverse Effects
AST (IU/L) after 7 months
|
27 International Units per Liter
Interval 12.0 to 90.0
|
24 International Units per Liter
Interval 10.0 to 55.0
|
SECONDARY outcome
Timeframe: baseline, after 3 months and after 7 monthsPopulation: adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis
Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney.
Outcome measures
| Measure |
Placebo Biscuit First Then Kothala Himbutu Biscuit Group
n=62 Participants
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
n=71 Participants
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
|
|---|---|---|
|
Renal Adverse Effects -1
eGFR (ml/min/1.73m^2) after 3 months
|
75.0 milliliters/minute/1.73m^2
Interval 39.0 to 90.0
|
75.0 milliliters/minute/1.73m^2
Interval 41.0 to 90.0
|
|
Renal Adverse Effects -1
eGFR (ml/min/1.73m^2) at baseline
|
77.1 milliliters/minute/1.73m^2
Interval 41.0 to 90.0
|
76.0 milliliters/minute/1.73m^2
Interval 41.0 to 90.0
|
|
Renal Adverse Effects -1
eGFR (ml/min/1.73m^2) after 7 months
|
75.0 milliliters/minute/1.73m^2
Interval 41.0 to 90.0
|
76 milliliters/minute/1.73m^2
Interval 41.0 to 90.0
|
SECONDARY outcome
Timeframe: Baseline, after 3 months, and after 7 monthsPopulation: adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis
Renal functions are described in the table below with higher serum creatinine suggesting injury to the kidney.
Outcome measures
| Measure |
Placebo Biscuit First Then Kothala Himbutu Biscuit Group
n=62 Participants
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
n=71 Participants
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
|
|---|---|---|
|
Renal Adverse Effects - 2
Serum creatinine (mg/dL) at baseline
|
0.94 milligrams per deciliter
Interval 0.04 to 1.84
|
0.94 milligrams per deciliter
Interval 0.1 to 1.47
|
|
Renal Adverse Effects - 2
Serum creatinine (mg/dL) after 3 months
|
0.98 milligrams per deciliter
Interval 0.7 to 1.97
|
0.96 milligrams per deciliter
Interval 0.62 to 1.7
|
|
Renal Adverse Effects - 2
Serum creatinine (mg/dL) after 7 months
|
0.97 milligrams per deciliter
Interval 0.6 to 1.8
|
0.93 milligrams per deciliter
Interval 0.61 to 1.39
|
Adverse Events
Placebo Biscuit Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Kothala Himbutu Biscuit Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Biscuit Group
n=131 participants at risk
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.
|
Kothala Himbutu Biscuit Group
n=129 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.76%
1/131 • Number of events 1 • seven months
Renal or urinary disorder and Hepato-biliary disorder were systematically collected. All other adverse events were monitored.
|
0.00%
0/129 • seven months
Renal or urinary disorder and Hepato-biliary disorder were systematically collected. All other adverse events were monitored.
|
Other adverse events
Adverse event data not reported
Additional Information
Professor Sisira Siribaddana
Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka
Phone: +94777326940
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place