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CTRI Number  CTRI/2024/03/063946 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Polycystic ovarian disease- (PCOD) 
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy of a Unani Polyherbal Formulation in the Management of Kesae-Khusyatur Raham (Polycystic Ovarian disease)- An open label single arm study 
Trial Acronym  PCOD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramsha Anwar  
Designation  MS Student 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital  
Address  Department of Ilmul Qabalat wa Amraz e Niswan OPD no 14 Ajmal Khan Road Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  8267988608  
Fax    
Email  ramshaanwar170@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suboohi Irshad 
Designation  Assistant Professor and Supervisor 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital 
Address  Department of Ilmul Qabalat wa Amraz e Niswan OPD no 14 Ajmal Khan Road Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  7291039942  
Fax    
Email  suboohialig58@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramsha Anwar  
Designation  MS Student 
Affiliation  Ayurvedic and Unani Tibbia College and Hospital  
Address  Department of Ilmul Qabalat wa Amraz e Niswan OPD no 14 Ajmal Khan Road Karol Bagh New Delhi

Central
DELHI
110005
India 
Phone  8267988608  
Fax    
Email  ramshaanwar170@gmail.com  
 
Source of Monetary or Material Support  
Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005 
 
Primary Sponsor  
Name  Ayurvedic and Unani Tibbia College and Hospital 
Address  Ayurvedic and Unani Tibbia College and Hospital Ajmal Khan Road Karol Bagh New Delhi 110005  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramsha Anwar   Ayurvedic and Unani Tibbia College and Hospital   Department of Ilmul Qabalat wa Amraz e Niswan OPD NO. 14 Ajmal Khan Road Karol Bagh New Delhi-05
Central
DELHI 		 8267988608

ramshaanwar170@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ayurvedic and Unani Tibbia College and Hospital Ethical Committee for MD/ MS (Unani)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N830||Follicular cyst of ovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Extract of Unani Polyherbal formulation containing Abhal (Juniperus communis), Hulba(Trigonella foelum gracum), Ashok(Saraca indica),Kachnaal(Bauhinia variegata),Kalonji(Nigella sativa), Zanjabeel(Zingiber officinalis), and Gul-e-surkh(Rosa damascena) filled in a capsule form.  2 capsules 500mg twice a day for 3 menstrual cycles/ months (withdrawal during menses). 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Women in age group of 18 to 45 years complaining of absence of menses (secondary amenorrhea) or complaining of increased duration of menstrual cycle associated with/ without increase in weight, acne and hirsutism.
2. Diagnosed cases of PCOD.
 
 
ExclusionCriteria 
Details  Patients having history of:
1. AIDS, cardiovascular disease, Diabetes mellitus, thyroid disease, renal disease, liver
disease, coagulation disorders or platelets dysfunction, anemic patient.
2. Women who are pregnant and lactating.
3. Systemic disease or malignancy.
4. Alcohol abuse or any other substance abuse. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Safe efficacious & cost effective drug from herbal source for the management of PCOD  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effects of unani polyherbal formulation in the improvement of quality of life of patient suffering from PCOD  3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 10/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ramshaanwar170@gmail.com].

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
This study is a open label single arm trial, to evaluate the efficacy and safety of the extract form of the Unani polyherbal formulation in the management of Polycystic ovarian syndrome, mainly secondary amenorrhea occurring due to PCOS and its manifestations by using modern parameters. PCOS is one of the most common cause of irregular periods and infertility. It starts to appear at 15-25 years of age and it may take years for its clinical appearance. The incidence of PCOS is 3-22%. Women with PCOS are at increased risk of infertility, recurrent miscarriages, endometrial cancer, late menopause and metabolic aberrations including type 2 Diabetes mellitus, dyslipidemia and cardiovascular diseases. Anxiety, depression and reduced quality of life are other complications associated with PCOS. Due to these complications, PCOS has become a distressing problem despite of advancement of modern science. Several agents are already being used such as hormone therapy for withdrawal bleeding and regulation of menstrual cycle and use of insulin sensitizing agents to reduce insulin resistance and androgens levels and Metformin, but these drugs have their own complications and side effects on long term use like venous thrombo-embolism, stroke, breast cancer, endometrial cancer and ovarian cancer, and long term use of metformin leads to Gastrointestinal side effects, etc. Therefore search for effective and safe drug is the need of the time especially from herbal source. Unani scholars have described principles of treatment for the management of secondary amenorrhea, acne and hirsutism. Many safe and effective single and compound drugs are identified in the classical Unani literature for the same purpose. Also in the recent past, few studies were conducted in the Indian subcontinent and the result of them were found very encouraging. Many single and also compound formulations are used in these studies. In the current study, we are planning to use the extract form of one such formulation to validate its efficacy and safety and to improve the quality of life of patients of Polycystic Ovarian Syndrome (PCOS).
 
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