CTRI/2019/03/018265Other3 期
An Open-Label, Prospective, Observational, Multiple-Dose, Controlled, Two Armed, Relative Study Of Bio Active Liquid Curcumin 5 Mg / 50 Ml (5 Drops In 50 Ml Of Water) Of Oral Dose (Tds Dose) Along With Conventional Pharmaceutical Treatment (Only Prescribed Diabetic Medicine) In Diabetic, Adult, Human Patients To Evaluate The Safety And Efficacy
Stabicon Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Diabetic adult human patients of age 18 years and above with a Body Mass Index(BMI) ranges between 18.5 kg/m2 and above according to the formula of BMI - weight (kg) / [height (m)]2)
- •2. Waist circumference of 102 centimeters (40 inches) or more in men, or 88 centimeters (35 inches) or more in women
- •3. Whose screening is performed within 29 days of check in
- •4. Patients whose screening laboratory values are within normal limits (including Fasting blood glucose CRP and HbA1c) or considered by the physician or Investigator to be of no clinical significance (laboratory tests are presented in Annexure IV)
- •5. Patients whose Screening Fasting blood glucose level will be at minimum 200 mg/dL and above.
- •6. HbA1c level will be 8% and above
- •7. Non-smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months
- •8. Non alcoholics are defined as someone who has completely stopped alcohol consumption for at least the past 03 months
- •9. 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
- •10. Generally healthy as documented by 12 lead electrocardiogram (ECG) X-Ray and clinical laboratory assessments
- •11. The Systolic pressure is >= 90 mmHg or above and for diastolic pressure is <= 140 mmHg or above
- •12. Patients willing to give written informed consent and adhere to all the requirements of this protocol
- •13. 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
- •14. Female patients within normal limits or clinically non significant laboratory evaluation results for FSH & LH
- •15. Female patients of childbearing potential practicing an acceptable non hormonal contraceptive method of birth control after consulting with investigator and/or surgically sterile (bilateral tubal ligation)
排除标准
- •1. Evidence of allergy or known hypersensitivity to Curcumin and its inactive ingredients.
- •2. Patients with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse and recently overcome or active existing tinnitus.
- •3. Patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- •4. Patients with Type I diabetes.
- •5. Any major illness in the last three months or any significant ongoing chronic medical illness.
- •6. Renal or liver impairment.
- •7. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
- •8. History of drug abuse within 03 months (including benzodiazepines, opioids, cocaine, morphine, barbiturates, THC and amphetamine etc.)
- •9. History of alcohol addiction or abuse.
- •10. History of difficulty in accessibility of veins.
- •11. Any blood donation / excess blood loss within 90 days of 1st visit.
- •12. Patient who had participated in any other study within the 90 days of study.
- •13. 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 1st visit and throughout the entire study.
- •14. Consumption of alcohol and its products, grapefruit and/ or its juice and poppy seeds containing foods within 72.00 hours prior to clinic admission and throughout the entire study.
- •15. Use of any prescribed medication within 14 days and any over the counter medicinal products, herbal medications, etc. within 07 days prior to study check in and throughout the study.
- •16. Pregnant and Lactating females.
- •17. 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.
- •18. 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.
- •19. Females likely to become pregnant during conducting of the study.
- •20. Use of hormone replacement therapy for a Period of 06 months prior to dosing.
- •21.Use of any oral contraceptives including estrogen and progestin combined pills and progestin only pills within 28 days prior to 1st visit dosing.
- •22. Ingestion of any hormonal agent at any time within 14 days prior to start of study visit.
- •23.Female subjects demonstrating a positive pregnancy screen.
- •24.Female subjects whose menstruation cycle coincides with the study visits.
- •25.Female subjects who are currently lactating.
- •26.Females likely to become pregnant during conducting of the study.
- •27.Use of hormone replacement therapy for a period of 06 months prior to dosing.
- •28.Use of any oral contraceptives including estrogen and progestin combined pills and progestin only pills within 28 days prior to 1st dosing of 00 visit
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