| CTRI Number |
CTRI/2013/10/004091 [Registered on: 23/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects coded Unani drug UNIM-904 with allopathic drug Amlodipine in patients with Essential Hypertension. |
|
Scientific Title of Study
|
A Multi centric, Single Blind, Randomized, parallel group
study to compare efficacy and safety of coded unani
formulation UNIM-904 with Amlodipine in patients with
Zaghtuddam Qawi Lazmi (Essential Hypertension)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZQ/HT/ UNIM 904/CCRUM |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director (Unani) |
| Affiliation |
in Unani Medicine (CCRUM |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-
New Delhi
DELHI
110058
India |
| Phone |
011-28521981 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director (Unani) |
| Affiliation |
in Unani Medicine (CCRUM |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-
New Delhi
DELHI
110058
India |
| Phone |
011-28521981 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director (Unani) |
| Affiliation |
in Unani Medicine (CCRUM |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-
New Delhi
DELHI
110058
India |
| Phone |
011-28521981 |
| Fax |
011-28522965 |
| Email |
ccrum605@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support :
1. Regional Research Institute of Unani Medicine(RRIUM), Mumbai
2. Regional Research Institute of Unani Medicine (RRIUM), Srinagar
3. Regional Research Institute of Unani Medicine (RRIUM), New Delhi
4. Central Research Institute of Unani Medicine (CRIUM), Hyderabad
Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MANZOOR AHMAD |
Central Research Institute of Unani Medicine (CRIUM), Hyderabad |
AG Colony road, Erragadda, Hyderabad- 500038
Hyderabad
ANDHRA PRADESH |
040-23810246
040-23811495
drsmanzoor@gmail.com |
| DR NAQUIBUL ISLAM |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE |
Naseem Bagh, Campus, University of Kashmir, Srinagar-190006
Srinagar
JAMMU & KASHMIR |
01942421604
01942421604
naquibislam@gmail.com |
| DR MUNAWWAR HUSSAIN |
Regional Research Institute of Unani Medicine(RRIUM), Mumbai |
Sir J.J. Hospital Compound, Byculla, Mumbai
Mumbai
MAHARASHTRA |
0122-23718706
0122-23718706
drmunawwar@yahoo.com |
| DR ABDUL RAHEEM |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, NEW DELHI |
D-11, Abul Fazal Enclave, Jamia Nagar, New Delhi-25
South
DELHI |
011-26952759
011-26952759
abdulraheem03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| CRIUM HYDERABAD INSTITUTIONAL ETHICS COMMITTEE, Hyderabad,DR MANZOOR AHMAD , Principal Investigator |
Approved |
| RRIUM MUMBAI INSTITUTIONAL ETHICS COMMITTEE, MUMBAI, DR MUNAWWAR HUSSAIN, PRINCIPAL INVESTIGATOR |
Approved |
| RRIUM NEW DELHI INSTITUTIONAL ETHICS COMMITTEE, NEW DELHI, DR ABDUL RAHEEM, PRINCIPAL INVESTIGATOR |
Approved |
| RRIUM SRINAGAR INSTITUTIONAL ETHICS COMMITTEE, SRINAGAR, JAMMU & KASHMIR, DR NAQUIBUL ISLAM, PRINCIPAL INVESTIGATOR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, Zaghtuddam Qawi Lazmi (Essential Hypertension) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Amlodipine |
Amlodipine 5 mg per day before breakfast
Duration of therapy: 12 weeks |
| Intervention |
UNIM-904 |
Formulation: UNIM-904 (Sachets containing 5 g granules) Route of administration: Oral
Dose regimen: 1 Sachet (5 g) BD ½ hr before breakfast and dinner
Duration of therapy: 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 18-65 years.
2. Patients of Hypertension with SBP 160-179 mmHg and DBP 90-100 mmHg
and/or
3.Presence of any of the following signs and symptoms:
•Suda (Headache)
•Duwar (Vertigo)
•Khafaqan (Palpitation)
•Kasal (Laziness)
•Qalaq (Anxiety)
•Usr al-Tanaffus (Breathlessness)
• Takaddur fi’l Hawas (Diminished Alertness)
•Jiryan al-Dam zer Multahima (Subconjunctival Haemorrhage)
•Ru’af (Epistaxis)
•Nabz Mumtali (Pulsus plenus)
|
|
| ExclusionCriteria |
| Details |
1.Patient with SBP ≥180 mmHg and DBP 100 mmHg
2.Patients of Secondary Hypertension
3.Pregnant and lactating women
4.Females using oral contraceptive pills
5.Patients taking any other medication affecting blood pressure like
NSAIDs.
6.Abnormality in investigations done at baseline (SGPT 105 IU)
7.Obese subjects – BMI 30
8.Disorders requiring long term-treatment, e.g, diabetes mellitus
9.Drug addicts, Alcoholics /Malignancy /Epilepsy /CAD/CKD
10.Patients with Sinus Bradycardia, i.e., pulse rate less than 60/min
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in Systolic and Diastolic BP
2.Improvements in signs and symptoms of Hypertension
3.Hematological and biochemical assessments for safety
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hematological and biochemical assessments for safety
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
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)
|
25/03/2013 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a multicentric controlled trial in patients with Zaghtuddam Qawi Lazmi (Essential Hypertension). The patient will be evaluated for hypertension at 3 consecutive visits at the same time & if blood pressure is found to be persistently high during rest (both mental and physical) the patient will be subjected to screening. After screening, participants will be divided into 2 arms. First arm will receive the study drug–UNIM-904 in the dose of 5 gm BD while the second arm will receive standard anti-hypertensive drug Amlodipine 5 mg OD. The total duration of treatment will be 12 weeks and the follow-up for all clinical parameters will be conducted weekly for 4 weeks and once in 2 weeks thereafter. The laboratory tests will be conducted at baseline, 2 weeks and last follow-up.
Composition of UNIM 904
Ud Salib…….2
1/2 parts
Kari
Patta……2 ½ Parts
Bahman e
Surkh..1 Part
|