A clinical study to determine the safety and efficacy of bio-active liquid Curcumin in diabetic, adult, human patients.
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/06/019636
- Lead Sponsor
- Stabicon Life Sciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Diabetic, adult, human patients of age 18 years and above with a Body Mass Index (BMI) ranges between 18.5 and above.
Waist circumference of 32 inch equal or more than for male and 30 inch equal or more than for female
Whose screening is performed within 29 days of check-in.
HbA1c level will be 6.5 % and above.
Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
Non- alcoholics. Non- alcoholics are defined as someone who has completely stopped alcohol consumption for at least the past 03 months.
Medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
Patients willing to give written informed consent and adhere to all the requirements of this protocol.
Willing to comply with all the requirements of study protocol and study-specific instructions given by the study personnel patient abstinence from any prescription medications within 14 days prior to study visit.
Female patients within normal limits or clinically non-significant laboratory evaluation results for FSH & LH and Serum Beta HCG.
Evidence of allergy or known hypersensitivity to Curcumin and its inactive ingredients.
Patients with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse and recently overcome or active existing tinnitus.
Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Patients with Type I diabetes.
Patients with Gallstones or a bile duct obstruction.
Any major illness in the last three months or any significant ongoing chronic medical illness.
Renal or liver impairment.
Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, psychosis or any other body system.
History of drug abuse within 03 months (including benzodiazepines, opioids, cocaine, morphine, barbiturates, THC and amphetamine etc).
History of alcohol addiction or abuse.
Any blood donation / excess blood loss within 90 days of 1st visit.
Patient who had participated in any other study within the 90 days of study.
Consumption of caffeine and /or Xanthine containing products (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and tobacco containing products Tobacco and tobacco products (like Khutkha, Pan/ Pan Masala, Beedi, Cigarettes) for at least 24.00 hours prior to screening and throughout the entire study.
Consumption of alcohol and its products, grapefruit and/ or its juice and poppy seeds containing foods within 72.00 hours prior to screening and throughout the entire study.
Pregnant and Lactating females.
An unusual or abnormal diet within 4 weeks prior to study check-in, for whatever
reason e.g. because of fasting due to religious reasons.
History of dehydration from diarrhea, vomiting or any other reason within a period of 48.00 hours prior to study check-in of each visit.
Females likely to become pregnant during conducting of the study.
Use of hormone replacement therapy for a Period of 06 months prior to dosing.
Use of any oral contraceptives including estrogen and progestin combined pills and progestin only pills within 28 days prior to 1st visit dosing.
Ingestion of any hormonal agent at any time within 14 days prior to start of study visit.
Female subjects demonstrating a positive pregnancy screen.
Female subjects who are currently lactating.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of oral Bio active Liquid Curcumin oral dose with conventional pharmaceutical treatment and only convectional medication in diabetic, adult, human patients.Timepoint: Visit 1- Visit- 6 (3Month)
- Secondary Outcome Measures
Name Time Method To evaluate the effect of oral Bio active Liquid Curcumin oral dose with conventional pharmaceutical treatment and only convectional medication in diabetic, adult, human patients.Timepoint: Visit 1- Visit- 6 (3Month)