| Trial ID: | L2276 |
| Source ID: | NCT02290925
|
| Associated Drug: |
Kothala Himbutu Biscuit
|
| Title: |
The Effect of Biscuit Containing Kothala Himbutu on Blood Glucose in Patients With Diabetes. A Randomized Control Study
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02290925/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Kothala Himbutu Biscuit|DIETARY_SUPPLEMENT: Placebo Biscuit
|
| Outcome Measures: |
Primary: 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) | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Rajarata University, Sri Lanka
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
133
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-05
|
| Completion Date: |
2017-04
|
| Results First Posted: |
2019-03-27
|
| Last Update Posted: |
2019-05-14
|
| Locations: |
Teaching Hospital Anuradhapura, Anuradhapura, North Central Province, 50000, Sri Lanka
|
| URL: |
https://clinicaltrials.gov/show/NCT02290925
|
