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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kothala Himbutu Biscuit | Drug | Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Haemoglobin | HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP | After 3 months and after 7 months (there is one month wash over period as this is a cross over trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Adverse Effects | liver functions are described in the table below with higher liver enzymes suggesting injury to the liver. | Baseline, after 3 months, and after 7 months |
| Renal Adverse Effects -1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadeesha Wickramasinghe, BSc | Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teaching Hospital Anuradhapura | Anuradhapura | North Central Province | 50000 | Sri Lanka |
Individual Patient Data (IPD) will be available for researchers.
10 years after end of the study (March 2019)
Any qualified researcher should submit the protocol and get the ERC clearence from institutional IRB (Ethics Review Committee, Faculty of Medicine & Allied Science, Rajarata University of Sri Lanka). After that they need to come to an written agreement with the researchers to analyze the data.
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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
All recruitment carried out in medical clinic, Teaching Hospital anuradhapura
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Period of Three Months |
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| Second Period of 3 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Biscuit First Then Kothala Himbutu Biscuit Group | 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 |
| BG001 | Kothala Himbutu First Then Placebo Biscuit Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycosylated Haemoglobin | HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP | Posted | Mean | Standard Error | percentage of glycosylated hemoglobin | After 3 months and after 7 months (there is one month wash over period as this is a cross over trial) |
|
seven months
Renal or urinary disorder and Hepato-biliary disorder were systematically collected. All other adverse events were monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Biscuit Group | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | death due to pneumonia |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Sisira Siribaddana | Faculty of Medicine & Allied Sciences, Rajarata University of Sri Lanka | +94777326940 | sisira.siribaddana@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2018 | Mar 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C034849 | BAG 0177 |
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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.
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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.
|
| Placebo Biscuit | Dietary Supplement | Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate) |
|
|
Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney.
| 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. | Baseline, after 3 months, and after 7 months |
| Insulin Started |
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| NOT COMPLETED |
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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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Glycosylated Haemoglobin | Blood samples were analyzed at a centrally accredited lab and HBA1c was measured using ion exchange high performance liquid chromatography standardized to NGSP | Mean | Standard Deviation | percentage of glycosylated haemoglobin |
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| Secondary | Liver Adverse Effects | liver functions are described in the table below with higher liver enzymes suggesting injury to the liver. | adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis | Posted | Mean | Full Range | International Units per Liter | Baseline, after 3 months, and after 7 months |
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|
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| Secondary | Renal Adverse Effects -1 | Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney. | adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis | Posted | Mean | Full Range | milliliters/minute/1.73m^2 | baseline, after 3 months and after 7 months |
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|
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| Secondary | Renal Adverse Effects - 2 | Renal functions are described in the table below with higher serum creatinine suggesting injury to the kidney. | adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis | Posted | Mean | Full Range | milligrams per deciliter | Baseline, after 3 months, and after 7 months |
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|
| 1 |
| 131 |
| 1 |
| 131 |
| 0 |
| 131 |
| EG001 | Kothala Himbutu 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. | 0 | 129 | 0 | 129 | 0 | 129 |
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| D004700 | Endocrine System Diseases |
| ALT (IU/L) after 3 months |
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| ALT (IU/L) after 7 months |
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| AST (IU/L) at baseline |
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| AST (IU/L) after 3 months |
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| AST (IU/L) after 7 months |
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| eGFR (ml/min/1.73m^2) after 3 months |
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| eGFR (ml/min/1.73m^2) after 7 months |
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| Serum creatinine (mg/dL) after 3 months |
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| Serum creatinine (mg/dL) after 7 months |
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