A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Haridra (Curcuma Longa) Drops (Curcuma Longa extract 5 mg, Curcuma longa Oleo resin 8.4 mg) in Prediabetic Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To Assess the impact of Haridra (Curcuma Longa) Drops on blood sugar control as measured by HbA1c levels
研究概览
简要总结
“A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Haridra (Curcuma Longa) Drops (Curcuma Longa extract 5 mg, Curcuma longa Oleo resin 8.4 mg) in Prediabetic Subjects.â€
Study Design
Type: Randomized, double-blind, placebo-controlled clinical trial.
Duration: 86 days per participant, including screening, enrollment, and treatment phases.
Sample Size: 30 prediabetic human adult participants.
Investigational Products:
Treatment 1: Haridra (Curcuma Longa) Drops (5 mg Curcuma Longa extract and 8.4 mg Curcuma Longa Oleo resin per dose).
Treatment 2: Placebo Drops.
Treatment Protocol
Participants will take 4 drops of Haridra or placebo in 50-100 ml of water, three times a day (before meals) for 12 weeks.
Study Objectives
Primary objective:
The primary objective of the study is to assess the efficacy of Haridra (Curcuma Longa) Drops compared to a placebo in Prediabetic Subjects.
Secondary objectives:
The secondary objective is to monitor the Safety and Tolerability of Haridra (Curcuma Longa) Drops compared to a placebo in Prediabetic Subjects.
Outcomes
Primary Outcomes:
To Assess the impact of Haridra (Curcuma Longa) Drops on blood sugar control as measured by HbA1c levels:
Glycated Hemoglobin (HbA1c) levels at baseline, after 6 weeks of treatment and upon completion of the study at 12 weeks.
Secondary Outcomes:
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. and address safety concerns of the product.
Fasting blood glucose levels at baseline and at the end of the study.
Serum insulin levels at baseline and at the end of the study.
Lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides) at baseline and at the end of the study.
Body weight and BMI at baseline and at the end of the study.
HOMA-IR assessment at baseline and at the end of the study.
Biomarkers:
TNF Alpha level in serum. (Elevated TNF Alpha is shown to be a risk factor in the progression of Diabetes through pre-diabetes.)
CRP, and
iii) IL-6
Safety Outcomes:
Safety Assessment such as Medical Examination, Vital signs throughout the study at specified time to ensure safety.
Laboratory parameters such as Haematology, Biochemistry, and serology will be assessed at the beginning and Haematology and Biochemistry at the end of the study to ensure safety.
Throughout the entire study duration, the frequency of adverse events (AE) will be monitored and recorded.
Study Visits
Participants will undergo a Screening Visit (to confirm eligibility), an Enrollment Visit (randomization and start of treatment), an Interim Visit (after 6 weeks for progress and safety checks), and an End-of-Treatment Visit (at 12 weeks for final assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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/m
- •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).
排除标准
- •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.
- •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.
结局指标
主要结局
To Assess the impact of Haridra (Curcuma Longa) Drops on blood sugar control as measured by HbA1c levels
时间窗: Glycated Hemoglobin (HbA1c) levels at baseline, after 6 weeks of treatment and upon completion of the study at 12 weeks.
次要结局
- 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.)
研究者
Dr Shailender Singh Tanwar
BioRadius Therapeutic Research Pvt. Ltd.