| CTRI Number |
CTRI/2025/08/092256 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| 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
|
Treatment of weakness of brain and memory (Zof-e-Dimag wa Hafiza) with Unani drugs Majoon Brahmi and Majoon e Nisyan
|
|
Scientific Title of Study
|
Comparative Clinical Validation study of Unani Pharmacopoeial Formulation Majoon Brahmi vs Majoon e Nisyan in Zof-e-Dimag wa Hafiza (Cerebro-asthenia) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZD/CA/MB/MN/CLNVAL/CCRUM/23-24 , Version No-01, 25.06.2025 |
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
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 India
South West
DELHI
110058
India |
| Phone |
09811810454 |
| Fax |
|
| Email |
javed.ghazal@gmail.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, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:
Clinical Research Unit, Cantonment General Hospital (Sotiganj) Begum Bridge, Meerut (Uttar Pradesh)-250001 |
| Monetary Support : 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-110058 |
|
|
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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shagufta Parveen |
Clinical Research Unit |
Research OPD Room Zof-e-Dimag wa Hafiza (Cerebro-asthenia), Cantonment General Hospital (Sotiganj) Begum Bridge, Meerut, UP-250001
Meerut
UTTAR PRADESH |
9718530779
Shaguf.ccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Meerut |
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 |
Majoon Brahmi |
5 gm BD with water for 6 weeks. |
| Comparator Agent |
Majoon e Nisyan |
5 gm BD with water for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of Zof-e-Dimag wa Hafiza (Cerebro-asthenia) having subjective complaints of cognitive impairment:
. Memory loss
. Mild headache
. speech impairment
. writing impairment
2. 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. Secondary causes of dementia including hypothyroidism or hyperthyroidism.
3. Known cases of B12 vitamin deficiencies.
4. Known case of chronic diseases 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
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The safety and efficacy of Unani Pharmacopeial formulation Majoon Brahmi in comparison with Majoon e Nisyan in Zof-e-Dimag wa Hafiza (Cerebro-asthenia) will be carried out on the basis of Mini Mental State Examination (MMSE) score |
At Baseline and after every 14 days, (i.e., 0, 14th,28th and 42th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline, at first follow up and at the end of treatment. (i.e., At 0, 14th and 42th day) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
15/08/2025 |
| 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
|
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 Single centric,Randomized, Parallel Group, Active Controlled trial in patients with Zof-e-Dimag wa Hafiza (Cerebro-asthenia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every 14days (i.e., Baseline, at days 14th, 28th, and 42th). The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 6 weeks (42 days). Laboratory parameters for safety assessment will be conducted at baseline, first follow-up and on completion of the protocol therapy (i.e., at 0, 14th and 42th day).
Composition of Majoon Brahmi | S. No. | Ingredients | Botanical Name | Quantity | | 1. | Agar | Aquilaria agallocha Roxb. | 20 gm | | 2. | Badiyan | Feoniculum vulgare Mill. | 40 gm | | 3. | Brahmi Boti | Bacopa monnieri (Linn). | 200 gm | | 4. | Banslochan | Bambusa bambos (L). | 40 gm | | 5. | Ilaichi Khurd | Elettaria cardamomum (L). | 20 gm | | 6. | Darchini | Cinnamomum zeylanicum Blume, | 10 gm | | 7. | Kishneez khushk (Dhaniya) | Coriandrum sativum Linn. | 40 gm | | 8. | Mastagi Roomi | Pistacia lentiscus Linn. | 20 gm | | 9. | Maghz Badam Shireen | Prunus amygdalus Batsch. | 100 gm | | 10. | Maghz Pista | Pistacia vera Linn. | 100 gm | | 11. | Qiwam Shakar | Sugar syrup | 1.8 kg |
Composition of Majoon Nisyan | S. No. | Ingredients | Botanical | Quantity | | 1. | Asärün(Tagar) | Valeriana wallichii DC | 20 gm | | 2. | Bädranjboyä | Melissa parviflora Benth | 20 gm | | 3. | Irsä | Iris ensata Thunb. | 20 gm | | 4. | Sumbul al-Tib | Nardostachys jatamansi DC | 20 gm | | 5. | Waj | Acorus calamus L. | 20 gm | | 6. | Behman Surkh | Salvia haematodes L. | 40 gm | | 7. | Post Halela Zard | Terminalia chebula Retz. | 40 gm | | 8. | Pipal Kalän | Piper longum L. | 10 gm | | 9. | Täj Qalmi | Cinnamomum cassia (L.) J. Presl | 20 gm | | 10. | Darchini | Cinnamomum zeylanicum Blume | 20 gm | | 11. | Darunaj Aqrabi | Doronicum hookeri C. B.Clarke ex Hook. f. | 20 gm | | 12. | Zanjbil | Zingiber officinale Roscoe | 10 gm | | 13. | Sa’ad Kufi | Cyperus scariosus R.Br. | 20 gm | | 14. | Ood Salib | Paeonia emodi Royle | 20 gm | | 15. | Filfil Siyah | Piper nigrum L. | 10 gm | | 16. | Kabab chini | Piper cubeba L. f. | 20 gm | | 17. | Kundur | Boswellia serrata Roxb.ex Colebr. | 20 gm | | 18. | Maghz-e-chironji | Buchanania lanzan Spreng. | 30 gm | | 19. | Maghz-e-Narjil | Cocos nucifera L. | 40 gm | | 20. | Abresham muqarraz | Bombyx mori(Silkworm) | 20 gm | | 21. | Mawiz Munaqqa | Vitis vinifera L. | 250 gm | | 22. | Za’fran | Crocus sativus L. | 1.8 gm | | 23. | Arq-i-Gaozban | Borago officinalis L. | 20 ml | | 24. | Mastagi rumi | Pistacia lentiscus L. | 20 gm | | 25. | Raughan zard | Pure Ghee | 5 gm | | 26. | Qiwam-e-Shakri | Sugar syrup | 1.3 kg |
|