| CTRI Number |
CTRI/2025/10/096623 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study to See if a Herbal Medicine Can Help People with Pre-Diabetes and Diabetes Manage Their Blood Sugar |
|
Scientific Title of Study
|
An Open-label, Multi-arm, Single-center Clinical Study to Evaluate the Safety and Efficacy of Polyherbal Extract as an Adjuvant Therapy in Subjects with Pre-diabetic, Moderately-diabetic, and Severely-diabetic Conditions. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2511 Version No 1.0 Dated 01 Jun 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G M Prasad |
| Designation |
Principal Investigator |
| Affiliation |
Pranav Diabetes Center |
| Address |
Ground Floor, Consultation Room No.1, 57/1, Nanda Complex Ramamurthynagar Main Road Banaswadi,
Bangalore
KARNATAKA
560043
India |
| Phone |
09731911630 |
| Fax |
|
| Email |
drgmprasad@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Navyug Global Ventures Pvt. Ltd.
Door No. 961, 1st Floor, Sugal Building, Poonamallee High Rd, Purasaiwakkam,
Chennai, Tamil Nadu - 600084. |
|
|
Primary Sponsor
|
| Name |
Navyug Global Ventures Pvt. Ltd. |
| Address |
Door No. 961, 1st Floor, Sugal Building, Poonamallee High Rd, Purasaiwakkam,
Chennai, Tamil Nadu - 600084. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G M Prasad |
Pranav Diabetes Center |
Ground Floor, Consultation oom No.1, 57/1, Nanda Complex Ramamurthynagar Main Road Banaswadi,
Bangalore
KARNATAKA |
09731911630
drgmprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (2) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (3) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Polyherbal + Standard of Care, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Arm- A (Prediabetic) Polyherbal Extract (Powder) 2 g orally twice daily (morning after breakfast, evening before dinner) with water for 90 days, combined with Standard of Care (Metformin ± diet). Sachets dispensed monthly. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Polyherbal + Standard of Care, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Arm- C (Severely Diabetic) Polyherbal Extract (Powder) 2 g orally twice daily (morning after breakfast, evening before dinner) with water for 90 days, combined with SOC (Metformin ± insulin/other antidiabetic drugs as per physician). Sachets dispensed monthly. | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Polyherbal Extract + Standard of Care, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Arm- B (Moderately Diabetic) Polyherbal Extract (Powder) 2 g orally twice daily (morning after breakfast, evening before dinner) with water for 90 days, combined with SOC (Metformin ± diet). Sachets dispensed monthly. | | 4 | Comparator Arm (Non Ayurveda) | | - | Standard of care | Metformin - commonly prescribed for both moderate and severe diabetes 500 mg to 1000 mg BID, Sulfonylureas orally twice daily for 90 days. |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between thirty and seventy-five years, of either gender.
2. Able and willing to provide written informed consent. For subjects aged sixty years and above, audio-visual consent is mandatory as per regulatory requirements.
3. Diagnosed as:
3.1 Prediabetic (HbA1c between five point seven percent and six point four percent)
3.2 Moderately diabetic (HbA1c greater than or equal to six point five percent)
3.3 Severely diabetic (HbA1c greater than or equal to eight point zero percent)
4. Stable on current diabetes medication for the past four weeks, if applicable.
5. Willing to comply with study procedures and visit schedule. |
|
| ExclusionCriteria |
| Details |
1. Diagnosis of any major systemic illness, including:
1.1 Malignancies
1.2 Chronic obstructive pulmonary disease (COPD)
1.3 Hepatobiliary disease
1.4 Severe cardiovascular disorders
1.5 Blood disorders
2. Known hyperlipidemia, hepatic dysfunction, renal dysfunction, or uncontrolled pulmonary dysfunction.
3. Poorly controlled hypertension.
4. Participation in any other clinical trial within the last three months.
5. Pregnant or lactating women.
6. Known allergy or intolerance to any component of the investigational product.
7. Unwillingness or inability to comply with study procedures or to sign informed consent.
8. Any condition that, in the investigator’s opinion, would interfere with study compliance or data interpretation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Glycosylated Hemoglobin (HbA1c)
o Measured from baseline (Visit 4) to Day 90 (Visit 7)
o Assesses long-term glycemic control over the 3-month treatment period
2. Change in Random Blood Sugar (RBS)
- Evaluated from baseline to the end of the study using both:
- Laboratory-based RBS measurements (Visits 1, 2, 3)
- Weekly glucometer readings (pre- and post-breakfast) recorded in subject diaries
Statistical Methods:
- Within-group comparisons: Paired t-test or Wilcoxon signed-rank test
- Between-group comparisons: ANOVA (parametric) or Kruskal-Wallis test (nonparametric),
followed by post hoc tests if significant.
- Effect Size: Mean ± SD, 95% confidence intervals. |
Screening Day -3,
Day -2 and Day -1
Randomization/Baseline Day 0
Day 30±2 Days,
Day 60±2 Days,
Day 90±2 Days,
Day 105±2 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in SF-36 Quality of Life scores
2. Descriptive analysis of improvement in physical and mental health domains
3. Compliance Rate (% sachets taken out of total dispensed) |
Screening Day -3,
Day -2 and Day -1
Randomization/Baseline Day 0
Day 30±2 Days,
Day 60±2 Days,
Day 90±2 Days,
Day 105±2 Days. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
09/11/2025 |
| 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) |
Open to Recruitment |
|
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
|
Brief Summary and Purpose of the Study This is an open-label, multi-arm, single-center clinical trial designed to evaluate the efficacy and safety of a Polyherbal Extract as an adjuvant therapy in subjects with prediabetes, moderate diabetes, and severe diabetes. A total of 80 subjects will be enrolled and assigned to one of four study arms based on their glycemic status: -
Arms A, B, and C: Polyherbal Extract + Standard of Care (SOC) -
Arm D (Control): SOC only The Polyherbal Extract is administered orally at 2 grams twice daily for 90 days alongside standard antidiabetic treatment (Metformin ± diet or insulin/other drugs as per physician). The study aims to: -
Primary objectives: -
Secondary objectives: -
Assess improvement in quality of life using the SF-36 questionnaire. -
Monitor safety and tolerability, including adverse events, vital signs, and liver/renal function tests. This study addresses the limitations of conventional diabetes treatments by exploring a plant-based, integrative approach, leveraging traditional herbal medicine in combination with standard care. The findings may provide evidence for a safe and effective adjunct therapy for glycemic management in the Indian population.
|