None listed
Conditions
Interventions
None listed
Sponsors
Lyrus Life Sciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Prediabetic human Subject (screened and confirmed by HbA1c 5.7-6.4%) of 18 to 65 years of age (both inclusive) and weighing at least 50 kg and Body Mass Index (BMI) between 25-35 kg/m2. 2.Subject who can provide adequate evidence of their identity and can be capable and willing to give informed written consent and to adhere to the study requirements. 3.Negative screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL. 4.Subject with normal pathology parameters or with abnormality considered to be clinically not significant judged by investigator. 5.Negative Breath alcohol test. 6.Subject individuals as evaluated by personal history, medical history and general medical examination and absence of significant disease judged by investigator. 7.Volunteer willing to use contraception consistently and correctly throughout the study duration. 8.Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (Beta-HCG) pregnancy test performed within 21 days prior to initiation of the study. 9.Female; currently not pregnant, not lactating, or not attempting to become pregnant for 4 weeks before the screening visit, throughout the duration of the study and 3 weeks after the subject’s last study-related visit (for eligible subjects only, if applicable), has a negative pregnancy test, and is of Non-childbearing potential, defined as: •greater than equal to year post-menopausal (no menstrual period for at least 12 consecutive months without any other medical cause) •Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Exclusion criteria
Exclusion criteria: 1. Significant history or presence of haemopoietic, cardiovascular, pulmonary,hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or any medical disorder deemed important by the investigator. 2.Diagnosed with type 1 or type 2 diabetes mellitus. 3.History of gastrointestinal bleeding or peptic ulcer disease. 4.History or presence of liver or kidney dysfunction. 5.History or presence of uncontrolled hypertension. 6.History of major surgery, depot injection, drug implant in the past 3 months, or dialysis. 7.History or presence of cancer. 8.Consumed alcohol within 48 hours before the study or difficulty abstaining during the study. 9.Consumed caffeine or xanthine products (coffee, tea, chocolate, etc.) during the study. 10.Consumed tobacco products, grapefruit, or grapefruit juice during the study. 11.History of allergy to vegetables, food substances, or any hypersensitivity reaction. 12.Present or past intake of medications that modify study medication kinetics/dynamics or deemed clinically significant by the investigator. 13.Positive screening result for HIV, Hepatitis B, Hepatitis C, or VDRL. 14.Intake of OTC products or herbal medications within 7 days prior to randomization. 15.Unusual diet (e.g., low sodium) for three weeks before randomization. 16.History of hypersensitivity to study medications, related medications, or formulation excipients. 17.Regular use of Curcumin supplements or medications interacting with Curcumin. 18.Any condition deemed unsuitable for participation by the investigator. 19.Females who are pregnant, lactating, planning to become pregnant, donating gametes during the study or for 3 weeks after the last study visit, or who have a positive serum pregnancy test at screening, and are unwilling to use appropriate contraceptive measures are excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Assess the impact of Haridra (Curcuma Longa) Drops on blood sugar control as measured by HbA1c levelsTimepoint: Glycated Hemoglobin (HbA1c) levels at baseline, after 6 weeks of treatment and upon completion of the study at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Haridra (Curcuma Longa) Drops on relevant biomarkers of diabetes, such as fasting blood glucose, insulin levels, lipid profile, inflammatory markers etc. & address safety concerns of the product. 1. Fasting blood glucose levels at baseline & at the end of the study. 2. Serum insulin levels at baseline & at the end of the study. 3. Lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) at baseline & at the end of the study. 4. Body weight & BMI at baseline & at the end of the study. 5. HOMA-IR assessment at baseline & at the end of the study.Timepoint: At Baseline/Screening Visit 1 & at end of the study Visit 4 | — |
Countries
India
Contacts
Public ContactDr Krishnaveni Gadiraju
BioRadius Therapeutic Research Pvt. Ltd.
Outcome results
None listed