| CTRI Number |
CTRI/2018/09/015692 [Registered on: 11/09/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Unani medicine Khamira Gawzaban Sada in Zu‘f al-DimÄgh (Cerebro-asthenia) |
|
Scientific Title of Study
|
Clinical Validation of a Unani Pharmacopoeial formulation –
Khamira Gawzaban Sada in Zu‘f al-DimÄgh (Cerebro-asthenia)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZD/C/KGS CLNVAL/CCRUM 15-16 version 1 |
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 |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
|
| 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 |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110028
India |
| Phone |
|
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer Scientist III |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110028
India |
| Phone |
|
| Fax |
|
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| InfrastructuralSupport:1.Central Research Institute of Unani Medicine, Hyderabad 2.Regional Research Institute of Unani Medicine Bhadrak 3. Regional Research Institute of Unani Medicine Mumbai Monetary Support : Central Council for Research in Unani Medicine, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| 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 Hina Rehman |
Central Research Institute of Unani Medicine (CRIUM) |
Research OPD,
Opposite ESI Hospital, AG Road, Erragadda
Hyderabad
ANDHRA PRADESH |
8297173005
hinarehman06@gmail.com |
| Dr Humiara Bano |
Regional Research Institute of Unani Medicine |
Sir JJ Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
09820711274
drhumairaalig2004@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Hyderabad |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G31||Other degenerative diseases of nervous system, not elsewhere classified, Zu‘f al-DimÄgh (Cerebro-asthenia), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Khamira Gawzaban Sada |
10 grams orally once daily to be taken with water before breakfast for six weeks |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The patients fulfilling the following criteria will be included in this study:
1. Patients of any sex in the age group 19-70 years
2. Patients of Zu‘f al-DimÄgh (Cerebro-asthenia) having:
 Subjective complaints of cognitive impairment
 MMSE score of 10-23 representing mild to moderate cognitive impairment
|
|
| ExclusionCriteria |
| Details |
1. Clinical presentation and/or history of any significant organic neurological diseases including space occupying lesions, stroke, head injury, seizure, and mental retardation
2. Patients with impairment of speech, hearing and vision, which can impede the interview for MMSE and QOL assessment
3. Known cases of hypothyroidism or hyperthyroidism
4. Vitamin B12 deficiency
5. Patients on Psychotropic Drugs
6. Clinical presentation and/or history of a chronic disease that requires long-term treatment, e.g., DM, tuberculosis, HIV infection, syphilis, CVD, pulmonary disease, CKD, chronic liver disease, or any other serious and/or unstable medical condition that, in the opinion of the investigator, could expose the patients to undue risk of a significant adverse event or interfere with assessment of safety or efficacy during the course of the trial
7. Pregnant and lactating women
8. H/o Addiction (alcohol, drugs)
9. H/o Hypersensitivity to the study drug or any of its ingredients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in signs and symptoms of Zu‘f al-DimÄgh (Cerebro-asthenia)
|
6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
at baseline and at the end of treatment |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/02/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
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 Zu‘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 2 weeks,
i.e., at days 14, 28, and 42 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 on completion of the protocol therapy.
|
S. No.
|
Ingredients
|
Botanical/Zoological/Chemical
Name
|
Quantity
|
|
1.
|
Abresham Muqarraz
|
Bombyx mori L. (Cocoon)
|
25 g
|
|
2.
|
Badranjboya
|
Melissa parviflora Benth.
|
175 g
|
|
3.
|
Berg Gawzaban
|
Borago officinalis L.
|
150 g
|
|
4.
|
Burada Sandal
Safaid
|
Santalum album Linn.
|
125 g
|
|
5.
|
Behman Surkh (Neem
Kofta)
|
Salvia haemetodes L.
|
100 g
|
|
6.
|
Tukhm Balangoo
|
Lallemantia royleana Benth.
|
125 g
|
|
7.
|
Tudri Surkh
|
Cheiranthus cheiri Linn.
|
50 g
|
|
8.
|
Kishneez Khushk
|
Coriandrum
sativum Linn.
|
150 g
|
|
9.
|
Gul-e-Khatmi
|
Althaea officinalis L.
|
50 g
|
|
10.
|
Gul-e-Gawzaban
|
Borago officinalis L.
|
50 g
|
|
11.
|
Shakar Safaid
|
Sugar (Saccharum officinale)
|
10 kg
|
|
12.
|
Sat Leemu
|
Citrus limon (L.) Burm. f.
|
20 g
|
|
13.
|
Natroon Banjawi
|
Sodium Benzoate
|
6 g
|
|