| CTRI Number |
CTRI/2026/01/102249 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Study to see the effect of pomegranate peel in patients with high blood pressure and diabetes. |
|
Scientific Title of Study
|
Effectiveness of pomegranate peel as an
adjunct to antihypertensive and hypoglycemic drugs treatment on Blood pressure, Hb1Ac, lipid profile
and oxidative stress among diagnosed Diabetes Mellitus II and Hypertensive patients at Health and
wellness center in Umred Block in Nagpur District: a cluster
randomized trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjan Solanki |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Community Medicine, 4th floor, room no 417, Plot no. 2, Sector-20, Mihan Nagpur, 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7264821671 |
| Fax |
|
| Email |
drranjansolanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjan Solanki |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Community Medicine, 4th floor, room no 417, Plot no. 2, Sector-20, Mihan Nagpur, 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7264821671 |
| Fax |
|
| Email |
drranjansolanki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjan Solanki |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Nagpur |
| Address |
Department of Community Medicine, 4th floor, room no 417, Plot no. 2, Sector-20, Mihan Nagpur, 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
7264821671 |
| Fax |
|
| Email |
drranjansolanki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology,
Technology Bhavan, New Mehrauli Road,,
New Delhi 110 016
Telephone 1126590215 |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
Department of Science and Technology,
Technology Bhavan, New Mehrauli Road,,
New Delhi 110 016
Telephone 11 26590215 |
| Type of Sponsor |
Government funding agency |
|
|
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 Ranjan Solanki |
All India Institute of Medical Sciences Nagpur |
Department of Community Medicine, 4th floor, room no 417, Plot no. 2, Sector-20, Mihan Nagpur, 441108
Nagpur
MAHARASHTRA |
7264821671
drranjansolanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHURARASATIYOGAH, (2) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pomegranate peel powder, Reference: Charaka Samhita, Sutrastana 27/144, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 18 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Conventional treatment | The control group will comprise patients each with Diabetes mellitus and hypertension who are receiving conventional treatment at the Health and Wellness Centre. The conventional treatment includes Amlodipine and Metformin. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are diagnosed with diabetes mellitus and hypertension, both on
conventional treatment (Metformin or Amlodipine) for at least 6 months of
duration
2. Willing and able to give informed consent for participation in the trial.
3. Patients who are willing to adhere to conventional care for the duration of the
trial
4. Individuals of any gender aged 18 years or above.
5. Patients on medication for Diabetes with good and fair control of Diabetes
mellitus (HbA1c 6.5-8)
6. Patients with grade 1 Hypertension, Systolic hypertension 140 -159 mmHg
and diastolic hypertension 90- 99 mmHg |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactation
2. History of allergy or drug hypersensitivity to any of the Ayurveda interventions
3. Having participated in other clinical trials within 12 weeks before the screening or
currently enrolled in another trial.
4. Known kidney disease
5. Patients with blood pressure greater than 159 mmHg Systolic or greater than 99 mmHg diastolic
6. Patients with HbA1c greater than 8.0 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Blood pressure, HbA1c, and Lipid Profile from baseline to Month 24 |
Baseline, 8 weeks, 24 weeks,48 weeks, 72 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Oxidative stress through d-ROMs (Reactive Oxygen-Free Radical Metabolites) from baseline to Month 18. |
Baseline, 8 weeks, 24 weeks,48 weeks, 72 weeks |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This cluster-randomised controlled trial aims to evaluate the effectiveness of pomegranate peel tablets as an adjunct to standard antihypertensive and hypoglycaemic therapy among adults diagnosed with Type II diabetes mellitus and grade-1 hypertension attending Health and Wellness Centres in Umred Block, Nagpur District. Eligible participants will continue to receive routine conventional treatment and will be allocated to either an intervention group receiving pomegranate peel tablets or a control group receiving standard care alone. The primary outcomes include changes in blood pressure, HbA1c, lipid profile, and oxidative stress parameters measured at baseline and at predefined follow-up intervals over an 18-month intervention period. The study seeks to generate evidence on the potential role of a pomegranate peel–based adjunct intervention in improving metabolic and cardiovascular outcomes in a community-based public health setting. |