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CTRI Number  CTRI/2025/02/080246 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   unani formulation for menstrual irregularity associated with polycystic ovaries 
Scientific Title of Study   Efficacy of Asgand and Khare khasak in polycystic ovarian syndrome- A Pilot Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr KOUSER FATHIMA FIRDOSE 
Designation  Assistant Professor 
Affiliation  National Institute of unani medicine 
Address  Room no.29-32National Institute of Unani Medcine, OPD KOTIIGEPALYA, MAGADI MAIN ROAD, BENGALURU
Room no.29-32 National Institute of Unani Medcine, OPD KOTIIGEPALYA, MAGADI MAIN ROAD, BENGALURU
Bangalore
KARNATAKA
560091
India 
Phone  09141762284  
Fax    
Email  kouser2fathima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr KOUSER FATHIMA FIRDOSE 
Designation  Assistant Professor 
Affiliation  National Institute of unani medicine 
Address  OPD no. 29-32, National Institute of Unani Medicine, kottigepalya magadi mainroad
Room no.29-32 National Institute of Unani Medcine, OPD KOTIIGEPALYA, MAGADI MAIN ROAD, BENGALURU
Bangalore
KARNATAKA
560091
India 
Phone  09141762284  
Fax    
Email  kouser2fathima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr KOUSER FATHIMA FIRDOSE 
Designation  Assistant Professor 
Affiliation  National Institute of unani medicine 
Address  OPD no. 29-32, National Institute of Unani Medicine, kottigepalya magadi mainroad
Room no.29-32 National Institute of Unani Medcine, OPD KOTIIGEPALYA, MAGADI MAIN ROAD, BENGALURU
Bangalore
KARNATAKA
560091
India 
Phone  09141762284  
Fax    
Email  kouser2fathima@gmail.com  
 
Source of Monetary or Material Support  
Admn block, 1st floor, National Institute of Unani Medicine, KOTIIGEPALYA, MAGADI MAIN ROAD, BENGALURU 
 
Primary Sponsor  
Name  Admn block st floor National Institute of Unani Medicine 
Address  KOTIIGEPALYA, MAGADI MAIN ROAD, BENGALURU 
Type of Sponsor  Research institution 
 
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 
Kouser Fathima Firdose  National Institute of unani medicine  National Institute of Unani Medicine, kottigepalya magadi mainroad
Bangalore
KARNATAKA 		 09141762284

kouser2fathima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Intitutional Ethical COmmittee, National Institute of unani medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Asgand (Withania somnifera Dunal) and Khare khasak (Tribulus terrestris Linn)   7 gms twice daily from 5th day of cycle for 21 days. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  USG findings of PCO with ovarian volume more than 10cm3
Oligomenorrhoea or amenorrhoea
Clinical evidence of hyperandrogenism ( Hirsuitism or Acne)
 
 
ExclusionCriteria 
Details  1. Patients with Hormonal treatment
2. Patients with History of DM, Hypertension, uncontrolled hypothyroidism
3. Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Menstrual regularity  Baseline and cyclical for 3 cycles 
 
Secondary Outcome  
Outcome  TimePoints 
USG Changes for ovarian volume.
 		 baseline and after 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/02/2025 
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)  Open to Recruitment 
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  

 

Objective: Efficacy of  Asgand and Kharkhask in   polycystic ovarian syndrome.

Source of Data:

     Patients attending NIUM Hospital, Bangalore

 Method of Collection of data:

  • Clinical History and Examination.
  • Laboratory Investigations.

Inclusion Criteria:

  1. Patients aged 18-35
  2. Oligomenorrhoea or amenorrhoea
  3. Clinical evidence of hyperandrogenism ( Hirsuitism / Acne)
  4. USG findings of PCO

Exclusion Criteria:

  1. Patients  with Hormonal treatment
  2. Patients with H/o DM, Hypertension
  3. Pregnant and lactating women. 16                                                                                                                                                                                                                                                                                                                                               

Sample size: 30 patients

Study design:  A Pilot study

Subjective Parameters:

1.      Oligomenorrhoea / Amenorrhoea

2.      Hirsutism

3.      Acne

Objective parameter:

1.      USG - Pelvis for ovarian volume

2.      Ferriman Gallwey score for hirsutism

3.      Acanthosis Nigricans Scale

Intervention:

Intervention: Asgand (Withania somnifera Dunal) and Khare khasak (Tribulus terrestris Linn)

Method of Preparation: Asgand and  Khare khasak will be taken in a ratio of 1:2 and safoof  will be prepared according to the standard method of preparation.

Route of Administration and Dosage:  7 gms twice daily from 5th day of cycle for 21 days.

Duration of Protocol Therapy: 3 cycles

Duration of Study: Two years

Follow up:

During treatment: After menstruation for 3 cycles.

After treatment: Once in the subsequent cycle.

Procedure of study:

Diagnosed cases of PCOS (n=30) in age group of 18-45 years will be included in the study after obtaining the written informed consent. 7 gm of  safoof of Asgand and Khare khasak with 5gms honey will be given twice daily from 5th day of cycle for 21 days     Follow up of the patients will be done after menstruation for 3 consecutive cycles during treatment and once in subsequent cycle after completion of treatment. Menstrual regulation, changes in FG score, Acanthosis  Nigricans  scale score and ovarian volume on ultrasound will be assessed during the study.

Withdrawal Criteria:

1.      Failure to follow the protocol.

2.      The cases in which drug adverse reactions will be noticed.

 Informed Consent:

Patients fulfilling the inclusion criteria mentioned above will be given the information sheet having details regarding the nature of study, and the drugs to be used. Patients will be given enough time to go through the study details mentioned in the information sheet. They will be given the opportunity to ask any question, and if they agree to participate in the study, they will be asked to sign the informed consent form.

 Assessment of Efficacy:

1.      Primary outcome measures - Menstrual regularity

2.      Secondary outcome measures – USG Changes for ovarian volume.

 Assessment of Safety:

1.      Clinical symptoms.

2.      Laboratory investigations.

 Adverse Effects Documentation:

Any adverse of drugs will be documented.

 Statistical Analysis:

The appropriate tests will be applied to analyse the data.

Investigations:

Pre test: RBS, Thyroid profile, Serum Prolactin

Pre-Test and Post Test: USG Pelvis for ovarian volume, Lipid profile, LFT, RFT.

 
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