| CTRI Number |
CTRI/2025/01/079662 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Unani formulation in heart failure |
|
Scientific Title of Study
|
Efficacy of Badranjboya as an add-on therapy in heart failure with reduced ejection fraction: 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 Zarif Alfeeq Bin Zainurmallal |
| Designation |
PG scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8527483787 |
| Fax |
|
| Email |
rushyysuf@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muzafar Din Ahmad Bhat |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Muzafar Din Ahmad Bhat |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, kottigepalya, Magadi Main Road, Bengaluru
Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9590366192 |
| Fax |
|
| Email |
drmuzaffar79@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, kottigepalya Magadi main road, Bengaluru- 560091, INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya Magadi Main Road, Bengaluru 560091 |
| 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 Zarif Alfeeq Bin Zainurmallal |
National Institute of Unani Medicine, Kottigepalya Magadi Main Road, Bengaluru |
NIUM Hospital (OPD No. 1 & 2) Department of Moalajat
Bangalore
KARNATAKA |
8527483787
rushyysuf@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Badranjboya (Melissa officinallis) |
Badranjboya will be powdered finely and fill in 833mg capsules Each patient will be given 5gm of the test drug per day in two divided doses with water after meal for 6 weeks |
| Comparator Agent |
Placebo |
wheat flour will be given 5 gm per day in two divided doses with water after meal for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants must have evidence of reduced left ventricular ejection fraction less than 50% and more than 30%.
Age 40 to 80 years, all genders
Voluntary participation and signing the informed consent.
Course of disease 3 months and above, stable condition in recent 1 month or receiving routine treatment with stable doses more than 1 month
Stage II and III Heart failure according to the New York Heart Association Classification
|
|
| ExclusionCriteria |
| Details |
Acute coronary syndrome occurred in the past 1 month
Plan to have cardiac surgery during the trial
Patients with History of cardiogenic shock acute myocarditis uncontrollable malignant arrhythmia hypertrophic obstructive cardiomyopathy pulmonary embolism or severe valvular disease requiring surgery
Participants with significant comorbidities such as renal dysfunction advanced cancer or terminal illness
Uncontrolled hypertension with systolic blood pressure 160 mmHg and above diastolic blood pressure 100 mmHg and above or hypotension less than 90/50 mmHg
With the History of kidney dysfunction eGFR 59 ml per minute per 1.73 square meters or less or active liver disease or AST ALT 3 times and above the upper limit of normal Severe chronic obstructive pulmonary disease
Psychiatric patients or patients with a history of depression alcohol or drug abuse
Pregnant women or breast feeding women or those who are trying to get pregnant during the trial
Participate in other clinical studies 3 months before this trial
Diabetic patients with HbA1c more than 8%
Inability to comply with study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the difference in 6 MWT |
0th 14th 28th and 42th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in heart function assessed by NYHA classifications
Improvement in left ventricular ejection fraction (LVEF) |
0th 14th 28th and 42th days |
|
|
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)
|
21/03/2025 |
| 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="6"
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
|
Purpose: To Evaluate the Efficacy of Badranjboya as an add-on therapy in heart failure with reduced ejection
fraction Design: A randomized, double-blind placebo-controlled trial Intervention: A test group will be given Badranjboya 5 grams per day in two divided doses, and a Placebo (Wheat flour) will be given in the same as of the test group. Main outcomes Measures: The Primary outcome is the difference in 6-minute walk test Secondary outcomes: Improvement in Heart function assessed by NYHA classification Improvement in Left Ventricular Ejection Fraction |