None listed
Conditions
Interventions
Intervention1: CUQ1720P: Oral administration of 500mg CUQ1720P capsules twice a day for 90 days
Control Intervention1: Not Applicable: Not applicable
Sponsors
Akay Flavours and Aromatics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects having weight > 50 Kg 2. Subjects who have no evidence of any underlying disease 3. Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device, oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test. 4. Must be willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1 Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart, thyroid and liver disease) requiring medical treatment 2 History of Chronic metabolic disease, Psychiatric illness,Drug abuse, smoking, abuse/addiction to alcohol,Eating disorder such as bulimia or binge eating,Endocrine abnormalities including stable thyroid disease, Cardiovascular surgery / History of any major surgery 3 Subjects allergic to herbal products 4 Known HIV or Hepatitis B positive or any other immuno-compromised state 5 Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subjectâ??s safety and preclude trial participation 6 Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study 7. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in liver function parameters from baseline to end of treatment(EOT)and over all safety of CUQ1720PTimepoint: Day 0,Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in other biochemical and hematological parametersTimepoint: Day 0,Day 90;changes in vital signsTimepoint: Day 0,Day 90 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed