| CTRI Number |
CTRI/2024/10/076028 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Severe pain in head with Unani medicine Habb-e-Mujarrrib |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopeial formulation Habb-e-Mujarrib in Shaqeeqa (Migraine) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| S/M/HM/CLNVLD/CCRUM/22-23, version 01, 07.06.22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
ghazala.javed@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1. Regional Research Institute of Unani Medicine, Aligarh
2. Clinical Research Unani, Kurnool; Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| 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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jawadul Haq |
Clinical Research Unit |
Research OPD Room, Shaqeeqa (Migraine), D.No.40/23, Park Road, Dr Abdul Haq Unani Medical college premises, Kurnool
Kurnool
ANDHRA PRADESH |
9502443555
cru.kurnool@gmail.com |
| DR PARVEZ KHAN |
Regional Institute of Unani Medicine (RRIUM) |
Research OPD Room, Shaqeeqa (Migraine),Post Box 70, Near Head Post Office
Aligarh
Aligarh
UTTAR PRADESH |
9411059371
waytoparvez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Kurnool |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Mujarrib |
1 gm pills to be taken orally twice daily with water for 12 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender in the age group 18- 65 years
2. Primary diagnosis of Migraine without aura by ICHD-3 beta as follows:
A. At least five attacks fulfilling criteria B–D.
B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated).
C. Headache has at least two of the following four characteristics:
Unilateral location
Pulsating quality
Moderate or severe pain intensity
Aggravation by or causing avoidance of routine
physical activity (e.g. walking or climbing
stairs).
D. During headache at least one of the following:
Nausea and/or vomiting.
Photophobia and phono phobia.
E. Not better accounted for by another ICHD-3 diagnosis |
|
| ExclusionCriteria |
| Details |
1. Known case of any structural brain abnormalities
2. Known case of Ocular disease
3. History of Ischemic stroke
4. Any disease involving sinus e.g. Rhinosinusitis
5. Systemic illness requiring long term treatment
6. Known cases of Chronic kidney & liver disease
7. Known cases of Psychiatric illness
8. Difficulty distinguishing migraine headache from other headaches
9. Known cases of Epilepsy and other neurological disorders
10. History of alcohol and drug abuse.
11. Pregnancy & lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of the study drug will be assessed on the basis of clinical parameters based on grading of symptoms, scoring of MIDAS and any change in rescue medication pattern. |
At baseline and at every two weeks till the completion of the trial i.e. upto 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination |
At baseline and at the end of treatment i.e. 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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 3 |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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="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
|
This study is designed as a multi centric open trial in patients with Shaqeeqa (Migraine). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every 2 weeks for 12 weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 12 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Habb-e-Mujarrib:
|
S. No.
|
Ingredients
|
Botanical Name
|
Quantity
|
|
1.
|
Sibr
|
Aloe barbadensis miller
|
1 g
|
|
2.
|
Chiraita sheeren
|
Swertia chirata
|
2 g
|
|
3.
|
Jauzbuba
|
Myristica fragrans
|
2 g
|
|
4.
|
Zeera safed
|
Cuminum cyminum
|
3 g
|
|
5.
|
Tukhm e karafs
|
Apium graveolens L
|
3 g
|
|
6.
|
Aab e kundush
|
Centipeda minima
|
Q.S.
|
|