| CTRI Number |
CTRI/2020/07/026544 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
09/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Cerebro-asthenia by Unani medicine Habbe
Jadwar Kochak |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Habb e Jadwar Kochak in Ḍu‘f al-DimÄgh (Cerebro-asthenia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DD/C/HJK/CLNVAL/CCRUM/18-19, Version 1, 16-04-19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No 523, Vth Floor
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 |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, 5th Floor,
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
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, 5th Floor,
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 Central Research Institute of Unani Medicine (CRIUM), Lucknow 2. Regional Research Institute of Unani Medicine (RRIUM), Patna 3. Regional Research Institute of Unani Medicine (RRIUM), Chennai 4. Regional Research Institute of Unani Medicine (RRIUM), Aligarh 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Najmus Sehar |
Central Research Institute of Unani Medicine (CRIUM) |
Research OPD Room Ḍu‘f al-DimÄgh (Cerebro-asthenia)
Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
7903422298
nsehar.ccrum@gmail.com |
| Dr K Kabiruddin Ahmed |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Ḍu‘f al-DimÄgh (Cerebro-asthenia)
1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU |
9444219145
drk.kabiruddin@rediffmail.com |
| Dr Md Manzar Alam |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Ḍu‘f al-DimÄgh (Cerebro-asthenia)
Guzri, Patna City
Patna
BIHAR |
9920245133
manzar.medicine@gmail.com |
| Dr Sheereen Afza |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Ḍu‘f al-DimÄgh (Cerebro-asthenia)
Post Box No. 70, Shahjahan Manzil, Near AMU Riding Club, Qila Road
Aligarh
UTTAR PRADESH |
9412596543
drafzasheereen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Chennai |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F488||Other specified nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habbe Jadwar Kochak |
125 mg Orally twice daily to be taken with water for 6 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patients fulfilling the following criteria will be included in this study:
1. Patients of either sex in the age group 40-65 years.
2. Patients of Ḍu‘f al-DimÄgh (Cerebro-asthenia) having subjective complaints of
cognitive impairment:
a. Memory loss
b. Mild headache
c. Anxiety
d. ButlÄn-i-Takallum (Speech impairment)
e. ButlÄn-i-TahrÄ«r (Writing impairment)
3. MMSE score of 10-23 representing mild to moderate cognitive impairment |
|
| ExclusionCriteria |
| Details |
The patients having any of the following criteria will be excluded from the study:
1. Clinical presentation and/or history of any significant organic neurological diseases
including space occupying lesions, stroke, head injury, seizure, and mental
retardation.
2. Secondary causes of dementia including hypothyroidism or hyperthyroidism.
3. Known cases of B12 vitamin deficiencies.
4. Clinical presentation and known case of a chronic disease that requires long-term
treatment.
5. Patients on Psychotropic Drugs
6. H/o alcohol or substance abuse or dependence.
7. H/o Hypersensitivity to the study drug or any of its ingredients
8. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Ḍu‘f al-DimÄgh (Cerebro-asthenia) |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and after every two weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
18/07/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 Ḍu‘f al-DimÄgh (Cerebro-asthenia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 6 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
|
S.
No.
|
Ingredients
|
Botanical
Name
|
Quantity
|
|
1.
|
Jadwar
|
Delphinium denudatum Wall.
|
10 g
|
|
2.
|
Banafsha
|
Viola odorata
|
10 g
|
|
3.
|
Zafran
|
Crocus sativus
|
10 g
|
|
4.
|
Ambar
Ash-hab
|
Ambra
grasea
|
5 g
|
|