| CTRI Number |
CTRI/2019/02/017822 [Registered on: 26/02/2019] Trial Registered Prospectively |
| Last Modified On: |
12/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Anaemia (Decrease in Red Blood Cells or Haemoglobin in Blood) with Unani medicine Habb-e-Khubs-ul-Hadeed |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Habb-e-Khubs-ul-Hadeed in Sū’ al-Qinya (Anaemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SQ/A/HKH/CLNVAL/CCRUM/17-18, 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 (CCRUM) |
| Address |
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 |
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 |
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 |
drpradeepkumar@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), New Delhi 3. Regional Research Institute of Unani Medicine (RRIUM), Mumbai Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM |
| 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Nafees |
Central Research Institute of Unani Medicine (CRIUM) |
Basaha, Kursi Road
Research OPD Room (Sū’ al-Qinya) (Anaemia)
Lucknow
UTTAR PRADESH |
9140705710
mnkccrum@yahoo.com |
| Dr Anwarul Islam |
Regional Research Institute of Unani Medicine (RRIUM) |
D 11, Abul Fazal Enclave, Jamia Nagar
Research OPD Room (Sū’ al-Qinya) (Anaemia)
South
DELHI |
9911926730
dranwarulislam@gmail.com |
| Dr Masroor Ali Qureshi |
Regional Research Institute of Unani Medicine (RRIUM) |
Behind Eye Bank, Sir J.J. Hospital Compound, Byculla
Research OPD Room (Sū’ al-Qinya) (Anaemia)
Mumbai
MAHARASHTRA |
9004040670
doctormasroorali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine, Lucknow |
Approved |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
| Regional Research Institute of Unani Medicine, New Delhi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Khubs-ul-Hadeed |
1 Tab orally twice
daily 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
· Patients of either sex in the age group 18-65 years.
· Patients not taking any other drugs for Sū’ al-Qinya (Anaemia) |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Patients having severe Anaemia (below 7gm/dl)
3. Patients having occult blood positive on stool examination.
4. Patients with chronic diseases requiring long-term treatment such as DM, T.B., HIV
infection, leukemia, endocrine disorders, Haemorrhagic diathesis (hemophilia, ITP),
bleeding piles, menorrhagia, metrorrhagia or any other serious and/or unstable illness
that, in the opinion of the investigator, could constitute a risk when taking study drug
or could interfere with the interpretation of data.
5. Patients with concurrent serious hepatic, cardiac, renal or pulmonary dysfunction.
6. Patients not willing to report for follow up. |
|
|
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 (Anaemia) |
12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
28/02/2019 |
| 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 (Anaemia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically fortnightly. 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 therapyComposition of Investigational Drug
|
S.
No.
|
Ingredients
|
Botanical
Name
|
Quantity
|
|
1.
|
Khabs-ul-Hadeed
|
Iron Oxide
|
400 g
|
|
2.
|
Habb-ul
Rashad
|
Lepidium Sativum
|
80 g
|
|
3.
|
Tukhm-e-Gandana
|
Allium
ascalonicum
|
10 g
|
|
4.
|
Tukhm-e-Jirjeer
|
Eruca
sativa
|
10 g
|
|
5.
|
Tukhm-e-Karafs
|
Apium
graveolens
|
10 g
|
|
6.
|
Tukhm-e-Gazar
|
Daucus
carota
|
10 g
|
|
7.
|
Tukhm-e-Turb
|
Raphanus
sativa
|
10 g
|
|
8.
|
Tukhm-e-Hulba
|
Trigonella
foenum- graecum
|
10 g
|
|
9.
|
Tukhm-e-Piyaz
|
Allium
cepa
|
10 g
|
|
10.
|
Heel
Khurd
|
Elettaria
cardamum
|
10 g
|
|
11.
|
Aab-e-Gandana
|
Allium
ascalonicum
|
Q.S.
|
|