Evaluating the Effects of Haridra (Curcuma Longa) Drops in Prediabetic Individuals: A Randomized, Double-Blind, Placebo-Controlled Study
Scientific Title of Study
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.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
427-24 Version: 00 Date: 21-Aug-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Shailender Singh Tanwar
Designation
Investigator
Affiliation
BioRadius Therapeutic Research Pvt. Ltd.
Address
BioRadius Therapeutic Research Pvt. Ltd., IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra, India.
Pune MAHARASHTRA 411057 India
Phone
9892023392
Fax
Email
drshailendersingh.bioradiuscro@gmail.com
Details of Contact Person Scientific Query
Name
Dr Senthil Thyagrajan
Designation
Head CRO
Affiliation
BioRadius Therapeutic Research Pvt. Ltd.
Address
BioRadius Therapeutic Research Pvt. Ltd., IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra, India.
Pune MAHARASHTRA 411057 India
Phone
9112126448
Fax
Email
head@bioradiuscro.com
Details of Contact Person Public Query
Name
Dr Krishnaveni Gadiraju
Designation
Director-Operations and Project Management
Affiliation
BioRadius Therapeutic Research Pvt. Ltd., Pune
Address
BioRadius Therapeutic Research Pvt. Ltd., IndiaLand Global Industrial Park, Plot No.8, S.No. 234, 235, 245, Hinjawadi Phase I, Pune, Maharashtra, India.
Pune MAHARASHTRA 411057 India
Phone
8806001545
Fax
Email
drkrishnaveni@bioradiuscro.com
Source of Monetary or Material Support
Lyrus Life Sciences Pvt. Ltd.
54 A and 54 B, Hoskote Industrial Area,
Hoskote Taluk,
Bangalore - 562 114, INDIA
Ph.: 91 80 27971982
Primary Sponsor
Name
Lyrus Life Sciences Pvt. Ltd.
Address
yrus Life Sciences Pvt. Ltd. 54 A and 54 B, Hoskote Industrial Area, Hoskote Taluk, Bangalore - 562 114, INDIA Ph.: 91 80 27971982
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Yogesh Popalghat
BioRadius Therapeutic Research Pvt. Ltd.
IndiaLand Global Industrial Park,
Plot No.8, S.No. 234, 235, 245,
Hinjawadi Phase I,
Pune- 411057, Maharashtra, India.
Ph.: +91-20-67789100 Pune MAHARASHTRA
9892023392
dryogeshpopalghat@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Skinovate Independent Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Prediabetic, willing, non-smoking, human, adult volunteers aged
between 18 to 65 years (inclusive of both) will be selected on the basis of screening procedures.
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Comparator Arm (Non Ayurveda)
-
Placebo Oral Drops
Manufactured by Lyrus Life Sciences Pvt. Ltd., India, Oral Drop Dosage Form,
Dose and Frequency -4 drops of Placebo in 50-100 ml of water thrice a day daily (morning, afternoon and evening).
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)
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pharmacy-controlled Randomization
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
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 Outcome
Outcome
TimePoints
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.
At Baseline/Screening Visit 1 & at end of the study Visit 4
Target Sample Size
Total Sample Size="30" Sample Size from India="30" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2
Date of First Enrollment (India)
11/11/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
“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€
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