| CTRI Number |
CTRI/2024/01/062052 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate anti-hypertensive and other health benefits of Moringa oleifera leaf extract in patients with essential hypertension |
|
Scientific Title of Study
|
Anti-hypertensive and pleiotropic effects of Moringa oleifera leaf extract as an add-on therapy in patients with essential hypertension - A randomized double blind placebo controlled 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 Harivenkatesh Natarajan |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Room No.4025, Department of Pharmacology, 3rd floor, Institute block, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9968856995 |
| Fax |
|
| Email |
dr.harivenkatesh82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harivenkatesh Natarajan |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Room No.4025, Department of Pharmacology, 3rd floor, Institute block, JIPMER, Puducherry
PONDICHERRY
605006
India |
| Phone |
9968856995 |
| Fax |
|
| Email |
dr.harivenkatesh82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadish M |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education & Research |
| Address |
Department of pharmacology,
JIPMER,
Gorimedu,
Dhanvantari Nagar, Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8220221876 |
| Fax |
|
| Email |
sadishakash2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Puducherry (Intra-mural Research Fund) |
|
|
Primary Sponsor
|
| Name |
JIPMER Puducherry |
| Address |
Jawaharlal Institute of Postgraduate Medical Education & Research(JIPMER), Gorimedu, Puducherry 605006 |
| 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 Sadish M |
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry |
Medicine OPD, Hypertensive Clinic, Department of Pharmacology, JIPMER, Puducherry
Pondicherry
PONDICHERRY |
8220221876
sadishakash2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee for Interventional Studies,JIPMER,Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical Placebo |
Identical Placebo 600 mg capsule thrice daily orally in addition to background standard antihypertensive agents for a period of 3 months |
| Intervention |
Moringa oleifera leaf extract |
Moringa oleifera leaf extract 600 mg capsule thrice daily orally in addition to background standard antihypertensive agents for a period of 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with essential hypertension aged ≥ 18 years, irrespective of gender, with or without other comorbidities, who fulfill the following criteria:
Patients on treatment with stable dose of antihypertensive agents for atleast 1 month and has not yet attained target blood pressure goals (130 mm Hg of systolic and 80 mm Hg of diastolic blood pressure) and not requiring dose escalation or addition of new anti-hypertensive agent according to clinical judgment of the treating physician.
|
|
| ExclusionCriteria |
| Details |
Patients with secondary hypertension.
Patients with resistant hypertension.
Patients with hypertensive urgency or emergency.
Patients not on stable dose of oral hypoglycemic drugs or insulin for past 1 month.
Pregnant and lactating women, women in reproductive age group not practicing contraceptive measures.
Patients with hepatic impairment (elevated liver enzymes more than 2 times upper normal limit)
Patients with renal impairment (serum Creatinine more than 1.2 mg per dl)
Patients with recent history of coronary artery disease
Patients with peripheral vascular disease.
Patients who had participated in other trials in the past three months.
Patients on other herbal medications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in systolic blood pressure at the end of 3 months |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in diastolic blood pressure, HbA1c level, oxidative stress marker and antioxidant level, hs-CRP, liver and renal function, lipid profile, serum uric acid level and endothelial function using plethysmography at the end of 3 months |
3 months |
| Safety of Moringa oleifera leaf extract in essential hypertension patients |
3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/02/2024 |
| 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="2"
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 study is a randomized double blind placebo controlled trial to evaluate the effect of Moringa oleifera leaf extract as an add on treatment in patients with essential hypertension. The study will have two arms- the intervention arm and the placebo arm. The study will be conducted with 150 participants, 75 in each group, all of whom will be recruited from JIPMER, Puducherry. The participants will receive either the intervention or placebo capsules at a dose of 600 mg thrice daily for a period of three months. At the end of three months, the participants will be assessed for mean reduction in systolic blood pressure, mean reduction in diastolic blood pressure, oxidative stress marker and antioxidant level, HbA1c level, liver and renal function test, lipid profile, hs-CRP, serum uric acid level and endothelial function using plethysmography and will be compared to baseline. |