| CTRI Number |
CTRI/2019/02/017786 [Registered on: 22/02/2019] Trial Registered Prospectively |
| Last Modified On: |
21/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Amenorrhea (absence of monthly menstrual periods) by Unani medicine Habb-e-Mudir |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Habb-e-Mudir in IhÌ£tibÄs al-Tamth (Amenorrhea) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IT/A/HM/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), Hyderabad 2. Central Research Institute of Unani Medicine (CRIUM), Lucknow 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 Arifa Khatoon |
Central Research Institute of Unani Medicine (CRIUM) |
Basaha, Kursi Road
Lucknow
UTTAR PRADESH |
9450023521
drarifakhan40@gmail.com |
| Dr Arzeena Jabeen |
Central Research Institute of Unani Medicine (CRIUM) |
A G Colony Road, Erragadda
Hyderabad
TELANGANA |
9032519286
aarzu763@gmail.com |
| Dr Nikhat Shaikh |
Regional Research Institute of Unani Medicine (RRIUM) |
Behind Eye Bank, Sir J J Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
9820399433
drnikhat.unani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine, Hyderabad |
Submittted/Under Review |
| Central Research Institute of Unani Medicine, Lucknow |
Approved |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N911||Secondary amenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Mudir |
1 Tab orally thrice daily after meals with water for 5 days from expected date of menses for 3 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Married /unmarried patients in the age group of 18-40 years.
2. Patients with secondary amenorrhoea.
|
|
| ExclusionCriteria |
| Details |
1. Patients with Primary Amenorrhea and primary ovarian failure
2. Patients with Hyperprolactinaemia
3. Patients with any systemic illness and malignancy
4. Pregnant and lactating woman
5. Known cases of bleeding disorders
6. Patients taking OCP’s / IUCD |
|
|
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 IhÌ£tibÄs al-Tamth (Amenorrhea) |
3 months |
|
|
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 IhÌ£tibÄs al-Tamth (Amenorrhea). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically for three consecutive cycles during treatment and two
cycle after treatment. During this period, menstrual cycle pattern were
assessed. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 3months. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. Composition of Habb-e-Mudir
|
S.No.
|
Ingredients
|
Scientific Name
|
Quantity
|
-
|
Sibr
|
Aloe barbadensis Linn.
|
2 gm
|
-
|
Hara Kasees
|
Ferrous sulphate
|
1 gm
|
-
|
Zafran
|
Crocus sativus Linn.
|
1 gm
|
|