FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/066997 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   relation between Female sexual problem and temperament  
Scientific Title of Study   Association between Female Sexual Dysfunction and Mizāj: A Case-Control Study 
Trial Acronym  FSDM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PROF DR ARSHIYA SULTANA 
Designation  Professor 
Affiliation  National Institute of Unani Medicine 
Address  Room No. 29, Dept. of Amraze Niswan wa Ilmul Qabalat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  09740915911  
Fax    
Email  drarshiya@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  PROF DR ARSHIYA SULTANA 
Designation  Professor 
Affiliation  National Institute of Unani Medicine 
Address  Room No. 29, Dept. of Amraze Niswan wa Ilmul Qabalat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  09740915911  
Fax    
Email  drarshiya@yahoo.com  
 
Details of Contact Person
Public Query  
Name  PROF DR ARSHIYA SULTANA 
Designation  Professor 
Affiliation  National Institute of Unani Medicine 
Address  Room No. 29, Dept. of Amraze Niswan wa Ilmul Qabalat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road

Bangalore
KARNATAKA
560091
India 
Phone  09740915911  
Fax    
Email  drarshiya@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore-560091, Karanataka 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  Room No. 29, OPD, Amraze Niswan Kottigepalya, Magadi Main Road,Bengaluru-560091, Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 
Prof Dr Arshiya Sultana  National Institute of Unani Medicine  Room No. 29, Dept of Ilmul Qabalat wa Amraze Niswan, Kottigepalya, Magadi Main Road
Bangalore
KARNATAKA 		 09740915911

drarshiya@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute of Unani Medicine, Institutional Ethics Committee for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F520||Hypoactive sexual desire disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Married women of reproductive age between 18-45 years old and a stable heterosexual relationship for at least 6 months 
 
ExclusionCriteria 
Details  Psychiatric disorder, undergone a radical hysterectomy or prolapse surgery or use of medication (that are known to influence sexual function).
If they had received hormone therapy within 3 months of recruitment.
Serious illnesses, breast, endometrial, or other gynecological malignancies.
Pregnant and lactating women within 3 months before the study
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Female sexual function index (FSFI)

 		 At first visit
 
 
Secondary Outcome  
Outcome  TimePoints 
Perceived stress scale
Validated questionnaire will be used for assessment of general Mizāj and uterine Mizāj  		 At first visit only 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Unani medicine, describes sexual dysfunction under the heading of Ḍu‘f al-Bāh as a condition in which sexual desire and capability to perform sexual activities decreases. Female Sexual Dysfunction (FSD) is an inability to attend and to maintain sexual activity, during sexual excitement there may inadequate lubrication, inability to maintain orgasm, decreased libido, pain during coitus, reduced sexual receptivity and pleasure, a diminished sense of wellbeing depressed mood (dysphoria) and reduced motivation and persistent unexplained fatigue. Decrease desire or interest/excitement is the most related symptoms and FSD affects 40% of the world’s females. It is estimated that during the lifetime 43% to 88% of females have at least one complaint of sexual problems. Hypoactive sexual desire dysfunctions (HSDD) are the most common problems presented in the Gynecological clinic which includes arousal disorder and sexual desire. The objective is to determine the relationship between Mizāj and female sexual dysfunction. Women with female sexual dysfunction (FSD) will be recruited.  FSD will be diagnosed according to the Female Sexual Function Index (FSFI) with total score ≤ 26.55 and perceived stress scale. Age matched (±2 years) healthy control women will be recruited. The assessment of various Unani parameters will be carried out by the standard scales available for them and the odd ratio and other appropriate statistics analysis will be calculated between the obtained scores and the Unani methods per se. Informed written consent will be obtained from each participant. While collecting the data, complete privacy will be maintained. Subjects with English literacy who can self-administer the questionnaire will be included. The data will be collected on e-google form. 
Close