| CTRI Number |
CTRI/2023/09/057339 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Neurasthenia (weakness in nerves) with Unani medicine Majoon-e-Lana |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopoeial formulation Majoon-e-Lana in Ḍu‘f A‘ṣÄb(Neurasthenia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DA/N/ML/CLNVAL/CCRUM/21-22, version 01 |
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 Naheed Parveen |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, 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 |
naheedparveen802@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV, Central Council for Research in Unani Medicine (CCRUM) |
| 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 (RRIUM), New Delhi 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 |
| 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 Lubna Fatima |
Regional Research Institute of Unani Medicine (RRIUM), New Delhi |
Research OPD Room,Ḍu‘f A‘ṣÄb(Neurasthenia),D-11, Abul Fazal Enclave, Jamia Nagar
New Delhi
DELHI |
7827433455
drfatima35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, New Delhi |
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-e-Lana |
5gm (semisolid) Orally twice daily to be taken with water after meals for 6 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either gender in the age group of 18-60 years
2. Patients having Ḍu‘f A‘ṣÄb(Neurasthenia) as per the diagnostic criteria
|
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 and above the age of 60 years
2. Patients having any systemic disease, chronic debilitating disease, T.B., Diabetes Mellitus etc.
3. History of any kind of addiction (Alcohol, Drugs and etc.)
4. Known case of Carpal tunnel syndrome, herniated disc syndrome, peripheral nerve injury.
5. Known cases of Any Neuromuscular abnormalities,neuromuscular junction disorders, Myasthenia gravis, Muscular disorders, Diabetic neuropathy, Autonomic neuropathies
6. Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of trial drug will be assessed on the basis of Clinical Global Impression (CGI) improvement of severity scale and the Visual Analogues Scales for the sense of fatigue and well-being. |
At every 2 weeks for 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline, 2nd week & at 6th week. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
Modification(s)
|
22/09/2023 |
| 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
|
Not yet |
|
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 open trial in patients with Ḍu‘f A‘ṣÄb(Neurasthenia). After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks. 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, 2nd week and on completion of the protocol therapy
Composition of Majoon-e-Lana | S. No. | Ingredients | Botanical / Scientific Name | Part Used | Quantity | | 1. | Azaraqi Mudabbar | Strychnos nux-vomica L. | Seed | 20g | | 2. | Filfil Safaid | Piper nigrum L. | Fruit | 10g | | 3. | Filfil Siyah | Piper nigrum L. | Fruit | 10g | | 4. | Darchini | Cinnamomum zeylanicum B. | Inner stem bark | 10g | | 5. | Filfil Daraz | Piper longum L. | Fruit | 10g | | 6. | Jauzbuwa | Myristica fragrans H. | Endosperm | 10g | | 7. | Bisbasa | Myristica fragrans H. | Arillus | 10g | | 8. | Mastagi | Pistacia lentisus L. | Resin | 10g | | 9. | Sad Kufi | Cyperus rotundus L. | Rhizome | 10g | | 10. | Zanjabeel | Zingiber officinale R. | Rhizome | 10g | | 11. | Qaranful | Syzygium aromaticum M. | Flower bud | 10g | | 12. | Aamla | Emblica officinalis G. | Fruit | 10g | | 13. | Sumbul-ut-Teeb | Nardostachys jatamansi D. | Rhizome | 10g | | 14. | Heel Khurd | Elettaria cardamomum M. | Fruit | 10g | | 15. | Nankhwah | Trachyspermum ammiL. | Fruit | 10g | | 16. | Badiyan | Foeniculum vulgare M. | Fruit | 10g | | 17. | Zafran | Crocus sativus L. | Stamen & Stigma | 10g | | 18. | Sandal Safaid | Santalum album L. | Heart wood | 10g | | 19. | Ood-e-Balsan | Balsamodendronopobalsamum K. | Wood | 10g | | 20. | Agar | Aquilariaagallocha | Heart wood | 10g | | 21. | Asal /Qand Safaid | Honey/Sugar | ---- | 600g | |