| CTRI Number |
CTRI/2015/03/005608 [Registered on: 04/03/2015] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and efficacy of Unani formulations in the treatment of Headache |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation – Arq Ajeeb for symptomatic releif in SudÄ‘ (Headache) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| S/H/AA CLNVAL/CCRUM 13-14 Version no 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF S SHAKIR JAMIL |
| Designation |
DIRECTOR GENERAL |
| Affiliation |
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
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
unanimedicine@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K M SIDDIQUI |
| Designation |
DEPUTY DIRECTOR |
| Affiliation |
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
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
01128522965 |
| Email |
ccrum507@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP KUMAR |
| Designation |
RESEARCH OFFICER SCIENTIST III |
| Affiliation |
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
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support 1 Regional Research Institute of Unani Medicine,Bhadrak 2.Regional Research Institute of Unani Medicine,Chennai 3.Regional Research Institute of Unani Medicine,Patna 4.Regional Research Institute of Unani Medicine,Mumbai 5.Regional Research Centre, Silchar 6.Clinical Research Unit,Karimganj 7.Clinical Research Unit,Kurnool Monetary Support : 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 = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR WAHIDUZZAMAN |
Clinical Research Unit (CRU), Karimganj |
Masjid Road, Karimganj
Karimganj
ASSAM |
03843267522
crukxj522@gmail.com |
| Dr Jawadul Haq |
Clinical Research Unit (CRU), Kurnool |
DR ABDUL HAQ UNANI MEDICAL COLLEGE, 40/23 PARK ROAD
Kurnool
ANDHRA PRADESH |
09502443555
cru.kurnool@gmail.com |
| DR MUSTEHASAN |
Regional Research Centre (RRC), Silchar |
S.M. Dev Civil Hospital, Silchar -1
Cachar
ASSAM |
03843267522
mustehasan1971@gmail.com |
| DR MOHAMMAD ZAKIR |
Regional Research Institute of Unani Medicine (RRIUM), Bhadrak |
Motel Chhak, Mathasahi
Bhadrak
ORISSA |
09040374465
urzakir@rediffmail.com |
| DR T SHAHIDA BEGUM |
Regional Research Institute of Unani Medicine (RRIUM), Chennai |
No.1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU |
04425955532
rriumchennai@gmail.com |
| DR MOHAMMAD NASEEM |
Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
Sir J J Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
0222371806
naseemrrium@gmail.com |
| DR MOHD WASIM AHMAD |
Regional Research Institute of Unani Medicine (RRIUM), Patna |
Manas Path opp. Patna City Hospital
Patna
BIHAR |
09555904810
mwasimahmed95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Clinical Research Unit (CRU), Karimganj |
Submittted/Under Review |
| Clinical Research Unit (CRU), Kurnool |
Approved |
| Regional Research Centre (RRC), Silchar |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Bhadrak |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Chennai |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R51||Headache, Headache (SudÄ), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arq Ajeeb |
Local application, Q.S, Twice daily,Apply locally on the forehead for seven days |
| Comparator Agent |
nil |
na |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Patients of either sex with age 18-65 years
• Patients having SudÄ‘ (Headache) with or without any of the following symptoms:
 Disturbed concentration
 Irritability
 Zu‘f al-IshtihÄ’ (Decreased appetite)
 I‘yÄ (Fatigue)
 Difficulty in falling asleep and staying asleep
 Mild sensitivity to light/ noise
|
|
| ExclusionCriteria |
| Details |
• Headache does not respond to standard therapy
• Headache accompanied by impaired neurological functions (loss of balance, weakness, numbness, or speech disturbances), double vision, seizures, mental disturbances, and loss of consciousness.
• Headache accompanied by persistent nausea, vomiting, fever and stiff neck
• History of recent head injury.
• Known cases of any other acute illness.
• Known cases of severe Renal/ Hepatic/ Cardiac ailments
• Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Sudđ (Headache) |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety |
7 days |
|
|
Target Sample Size
|
Total Sample Size="540"
Sample Size from India="540"
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)
|
03/03/2014 |
| 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 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 open trial in patients with Arq Ajeeb in Sudđ (Headache). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically on
3rd and 7th day of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be one week. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.Composition of Arq Ajeeb
|
S. No.
|
Unani Name
|
Botanical Name
|
Weight
|
|
1.
|
Kafoor
|
Cinnamomum
camphora
|
20 g
|
|
2.
|
Jauhar-e- Pudina
|
Mentha
arvensis
|
20 g
|
|
3.
|
Jauhar-e- Ajwayin
|
Trachyspermum
ammi
|
10 g
|
|