| CTRI Number |
CTRI/2025/12/098814 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Shigru (Moringa oleifera) Leaf Powder as an Add-on to Standard of Care in Metabolic Syndrome |
|
Scientific Title of Study
|
Open-Label, Randomized Controlled Trial Protocol to Evaluate the Efficacy and Safety of Shigru (Moringa oleifera) Leaf Powder as an Add-on to Standard of Care for Glyeemic Control in Patients with Metabolic Syndrome at AIIMS Bhopal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Danish Javed |
| Designation |
Senior Medical Officer (Ayush) |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Ayush, AIIMS, Saket nagar, Bhopal,Madhya Pradesh, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9654978285 |
| Fax |
|
| Email |
danish.ayush@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Danish Javed |
| Designation |
Senior Medical Officer (Ayush) |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Ayush, AIIMS, Saket nagar, Bhopal,Madhya Pradesh, India
MADHYA PRADESH
462020
India |
| Phone |
9654978285 |
| Fax |
|
| Email |
danish.ayush@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Danish Javed |
| Designation |
Senior Medical Officer (Ayush) |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Department of Ayush, AIIMS, Saket nagar, Bhopal,Madhya Pradesh, India
MADHYA PRADESH
462020
India |
| Phone |
9654978285 |
| Fax |
|
| Email |
danish.ayush@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Saket Nagar, Bhopal, Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhopal |
| Address |
All India Institute of Medical Sciences, Saket Nagar, Bhopal, Madhya Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Danish Javed |
All India Institute of Medical Sciences Bhopal |
Department of Ayush, AIIMS, Saket nagar, Bhopal,Madhya Pradesh, India
Bhopal
MADHYA PRADESH |
9654978285
danish.ayush@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E889||Metabolic disorder, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Moringa oleifera leaf powder, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Add on to with standard of care (Oral Hypoglycemic agents: Metformin 500 mg and Glimepiride 1 mg, twice a day) | | 2 | Comparator Arm (Non Ayurveda) | | - | standard of care Oral Hypoglycemic agents | Metformin 500 mg and Glimepiride 1 mg, twice a day, for 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 30 to 65 years visiting outpatient department of AIIMS Bhopal
Diagnosed with metabolic syndrome and having HbA1C between 6.5 to 8.0.
Patients maintaining stable health conditions and not requiring any acute or long term medication for hypertension, dyslipidemia or obesity management.
Willing to comply with protocol and follow up
Provide informed written consent |
|
| ExclusionCriteria |
| Details |
Patients receiving oral hypoglycemic medications other than glimepiride or metformin
Patients receiving any medications such as antihypertensive, obesity, and hyperlipidemia
drugs.
Severe Cardiac or hepatic or renal disease
Acute cases with Diabetic complications such as ketoacidosis
Any malignancy
Pregnant or lactating women
Allergic to herbal supplements
Already using Moringa or any similar herbal interventions
Living outside Bhopal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Glycemic Markers (HbA1c) |
From baseline (day 0) to
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting Blood Glucose |
From baseline (day 0) to
12 weeks |
Postprandial Blood
Glucose |
From baseline (day 0) to
12 weeks |
| Serum Insulin (HOMA-IR) |
From baseline (day 0) to
12 weeks |
| C-peptide |
From baseline (day 0) to
12 weeks |
| Weight |
From baseline (day 0) to
12 weeks |
| Waist-Hip Ratio |
From baseline (day 0) to
12 weeks |
| Systolic and diastolic Blood Pressure |
From baseline (day 0) to
12 weeks |
| Lipid Profile |
From baseline (day 0) to
12 weeks |
| High-sensitivity C-reactive Protein (hs-CRP) |
From baseline (day 0) to
12 weeks |
Liver
Function Tests |
From baseline (day 0) to
12 weeks |
| Renal Function Tests |
From baseline (day 0) to
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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="1"
Months="0"
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
|
Metabolic Syndrome is a common health condition where several problems such as high blood sugar, high blood pressure, obesity, and abnormal cholesterol levels occur together. In India, nearly one out of every three people suffers from this condition. It greatly increases the risk of heart disease, stroke, kidney problems, and even early death. Usual treatment includes medicines like metformin and glimepiride (for blood sugar), statins (for cholesterol), and various blood pressure medicines. Although these treatments are effective, many patients still struggle to control their blood sugar and face side effects or long term risks. This makes it important to explore safe and affordable additional options. Moringa oleifera, commonly known as Shigru or the drumstick tree, is a plant widely used in Ayurveda. It is rich in nutrients and has been shown in several studies to help in diabetes, cholesterol problems, and high blood pressure. According to Ayurveda, Shigru is known to reduce Kapha and fat-related disorders, which are closely linked with lifestyle diseases. Modern research suggests that Moringa helps control blood sugar and cholesterol through multiple actions in the body, such as improving insulin sensitivity and reducing inflammation. This study will test whether adding Moringa leaf powder to standard diabetes treatment gives better results compared to standard treatment alone in patients with metabolic syndrome. The study will be conducted at AIIMS Bhopal. A total of 110 patients between 30–65 years of age, diagnosed with metabolic syndrome, will be randomly divided into two groups. Group A (Intervention group) Will receive 12 grams of Moringa leaf powder daily (6 g twice a day) along with standard medicines (Metformin and Glimepiride). Group B (Control group) Will receive only the standard medicines. Both groups will also receive diet and lifestyle counselling, including advice on walking, proper sleep, and avoiding alcohol or tobacco. The study will last for 12 weeks, with check ups at 4, 8, and 12 weeks. The main measure of success will be improvement in blood sugar control (HbA1c levels). Other outcomes like weight, waist size, blood pressure, cholesterol, liver and kidney health, and any side effects will also be checked. If Moringa proves effective and safe, it could become a low cost, natural supplement to routine treatment, improving patient outcomes and reducing long-term risks. This may provide a bridge between modern medicine and Ayurveda, offering holistic benefits for people with metabolic syndrome. |