| CTRI Number |
CTRI/2025/11/097749 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| 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 Amenorrhea (absence of monthly menstrual periods) with Unani medicine Qurs-e-Foh and Hab-e-Mudir. |
|
Scientific Title of Study
|
Comparative Clinical validation study to assess the safety and efficacy of Unani pharmacopoeial formulation Qurs-e-Foh vs Hab e Mudir in Ehtebas-e-Tams (Amenorrhea) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IT/A/QF/HM/CLNVAL/CCRUM/23-24, Version No-01, 20-06-2025 |
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: Central Research Institute of Unani Medicine, Post & village, BasahaKursi Road, Lucknow – 226026 (Uttar Pradesh) |
| 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 Arifa khatoon |
Central Research Institute of Unani Medicine |
Research OPD Room Amenorrhea, RRIUM, Post & village, BasahaKursi Road,
Lucknow – 226026
Lucknow
UTTAR PRADESH |
8619725706
drarifakhan40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine |
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 |
| Comparator Agent |
Hab e mudir |
2 Tab (500mg each) thrice Daily, after meals with water for 5 days. |
| Intervention |
Qurs-e-Foh
|
2 Tab(500mg each) thrice Daily, after meals with water for 5 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients complaining of absence of menstruation for last 3 or more months.
2. Patients with secondary amenorrhoea. |
|
| ExclusionCriteria |
| Details |
1. Patients with primary amenorrhea and primary ovarian failure
2. Patients with thyroid dysfunction, PCOD, hyperprolactinaemia
3. Patients with any systemic illness and malignancy
4. Pregnant and lactating woman
5. Patients with bleeding disorders
6. Patients taking Oral Contraceptive Pills(OCPs) /Intra- Uterine contraceptive devices (IUCDs) |
|
|
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 Qurs-e-Foh in comparison with Hab e Mudir in Ehtabas-e-Tams (Amenorrhea) will be carried out on the basis of PBAC (Pictorial blood loss assessment chart) score. |
At baseline, at the 1st follow-up (1st menstrual cycle), at the 2nd follow-up (2nd menstrual cycle), and at the 3rd follow-up (3rd menstrual cycle), i.e., 0 and three consecutive menstrual cycles. (The patient is advised to report 5 days prior to the expected date of the menstrual period)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haematological and biochemical investigations for safety assessment i.e., Hemogram, LFT,KFT, Urine Examination: Routine & Microscopic.
|
At baseline and at the end of treatment. i.e., 0 and 3rd menstrual cycle
|
|
|
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)
|
05/12/2025 |
| 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 Ehtabas-e-Tams (Amenorrhea) . After screening, the Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically for three consecutive menstrual cycles during the course of treatment. The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 3 months. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Test formulation- Qurs-e-Foh | S.No. | Ingredients | Scientific Name | Quantity | -
| Foh (Majeeth) | Rubia cordifolia Linn. | 450 mg | -
| Irsa | Iris ensata Thunb. | 10 mg | -
| Post-e-Bekh-e-Kabar | Capparis spinosa Linn. | 10 mg | -
| Zarawand Taweel | Aristolochia rotunda Linn. | 10 mg | -
| Sikanjabeen | - | Q.S |
Comparator formulation- Hab -e-Mudir | S.No. | Ingredients | Scientific Name | Quantity | | 1. | Sibr | Aloe barbadensis Linn. | 2 gm | | 2. | Hira Kasees | Ferrous sulphate | 1 gm | | 3. | Zafran | Crocus sativus Linn. | 1 gm | |