| CTRI Number |
CTRI/2020/07/026569 [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 decrease in hemoglobin levels by Unani medicine Majoon Khabs-ul-Hadeed |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Majoon Khabs-ul-Hadeed in Sū’ al-Qinya (Iron deficiency Anaemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SQ/A/MKH/CLNVAL/CCRUM/18-19, Version 1, 11-04-19 |
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
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.Regional Research Institute of Unani Medicine, Patna 2.Regional Research Institute of Unani Medicine, Kolkata 3.Regional Research Centre, Allahabad 4.Regional Research Centre, Silchar 5.Central Research Institute of Unani Medicine, Lucknow 6.Clinical Research Unit, Burhanpur 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 = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Nafees Khan |
Central Research Institute of Unani Medicine (CRIUM) |
Research OPD Room Sū’ al-Qinya (Iron deficiency Anaemia)
Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
9140705710
mnkccrum@yahoo.com |
| Dr Mujahid Sami |
Clinical Research Unit (CRU) |
Research OPD Room Sū’ al-Qinya (Iron deficiency Anaemia)
Ganpati Naka
West Nimar
MADHYA PRADESH |
09827541428
mahajankk@rediffmail.com |
| Dr Akhter Hussain Jamali |
Regional Research Centre (RRC) |
Research OPD Room Sū’ al-Qinya (Iron deficiency Anaemia)
S M Dev Civil Hospital, Silchar
Cachar
ASSAM |
8811907160
crukxj522@gmail.com |
| Dr Mohd Ehsan Ansari |
Regional Research Centre (RRC) |
Research OPD Room Sū’ al-Qinya (Iron deficiency Anaemia)
B-501/4, G T B Nagar (Opposite Dulhan Palace)
Allahabad
UTTAR PRADESH |
8887801120
dr.mehsan.ansari786@gmail.com |
| Dr Rajesh |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Sū’ al-Qinya (Iron deficiency Anaemia)
Guzri, Patna City
Patna
BIHAR |
8544424965
drrajesh.baba@gmail.com |
| Dr Younis Iftekhar Munshi |
Regional Research Institute of Unani Medicine (RRIUM) |
Research OPD Room Sū’ al-Qinya (Iron deficiency Anaemia)
First Floor, 250A/29, G T Road (North), Near Jaiswal Hospital, Liluah, Howrah
Kolkata
WEST BENGAL |
9419086700
younismunshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Submittted/Under Review |
| Clinical Research Unit (CRU), Burhanpur |
Submittted/Under Review |
| Regional Research Centre (RRC), Allahabad |
Submittted/Under Review |
| Regional Research Centre (RRC), Silchar |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Kolkata |
Submittted/Under Review |
| 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: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon Khabs-ul-Hadeed |
5 gm Twice daily Orally to be taken with water after meals for 12 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having mild (10.0-11.9 g/dl) to moderate (7.0-9.9 g/dl) Anaemia |
|
| ExclusionCriteria |
| Details |
1. Patients having severe Anaemia (below 7gm/dl)
2. Patients with excessive bleeding e.g. bleeding piles, menorrhagia, metrorrhagia etc
3. Known cases of chronic diseases on long term treatment.
4. Patients with concurrent serious hepatic, cardiac, renal dysfunction.
5. 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 signs and symptoms of Sū’ al-Qinya (Iron deficiency Anaemia) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at 0, 4, 8, 12 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)
|
19/07/2020 |
| 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
|
Not 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 Sū’ al-Qinya (Iron deficiency Anaemia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Majoon Khabs-ul-Hadeed 5 gm daily orally with water after meals for 12 weeks. The patients will be assessed at 0, 4, 8, 12 weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 12 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition of Majoon Khabs-ul-Hadeed
|
S.
No.
|
Ingredients
|
Botanical
Name
|
Quantity
|
|
1.
|
Tukhm Hummaz Biryan
|
Rumex vesicarius L.
|
10 g
|
|
2.
|
Habb-ul
Aas Biryan
|
Myrtus communis L.
|
10 g
|
|
3.
|
Post
Halela Zard
|
Terminalia Chebula
|
10 g
|
|
4.
|
Aamla
Biryan
|
Phyllanthus emblica
|
10 g
|
|
5.
|
Post
Beekh Anjabar
|
Fumaria parviflora
|
10 g
|
|
6.
|
Halela
Siyah
|
Terminalia Chebula
|
10 g
|
|
7.
|
Busud
|
Corallium rubrum
|
10 g
|
|
8.
|
Kehruba
|
Vateria indica gum
|
10 g
|
|
9.
|
Khabs-ul-Hadeed Mudabbar
|
Iron Oxide
|
20 g
|
|
10.
|
Rubb
Seb Shireen
|
Malus domestica
|
100 g
|
|
11.
|
Sharbat
e Behi
|
Cydonia oblonga
|
150 g
|
|
12.
|
Asl
or Qand Safaid
|
Honey
|
150 g
|
|