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CTRI Number  CTRI/2026/03/106686 [Registered on: 23/03/2026] Trial Registered Prospectively
Last Modified On: 23/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   study to evaluate benefits of leech therapy in endometriosis 
Scientific Title of Study   The effect of leech therapy in endometriosis an amphispective clinical study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Suhasini 
Designation  Professor 
Affiliation  Government nizamia tibbi college 
Address  PG Dept of gynaecology and obstetrics Government nizamia tibbi college
Charminar Hyderabad
Hyderabad
TELANGANA
500002
India 
Phone  9949586899  
Fax    
Email  drasuhasini12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arshiya Sultana 
Designation  Professor 
Affiliation  National Institute of Unani Medicine 
Address  PG Dept of gynaecology and obstetrics National Institute of Unani Medicine Kottigepalya magadi main road Bangalore
Bangalore Karnataka
Bangalore
KARNATAKA
560091
India 
Phone  9740915911  
Fax    
Email  drarshiya@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr A Suhasini 
Designation  Professor 
Affiliation  Government nizamia tibbi college 
Address  PG Dept of gynaecology and obstetrics Government nizamia tibbi college
Charminar Hyderabad TG
Hyderabad
TELANGANA
500002
India 
Phone  9949586899  
Fax    
Email  drasuhasini12@gmail.com  
 
Source of Monetary or Material Support  
Government nizamia tibbi college and general hospital charminar hyderabad telangana 500002 
 
Primary Sponsor  
Name  Government nizamia tibbi college 
Address  Charminar hyderabad TG 
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 A Suhasini  Government nizamia tibbi college  Gynaecology OPD room no 8
Hyderabad
TELANGANA 		 9949586899

drasuhasini12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government nizamia tibbi college institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N809||Endometriosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hirudinaria granulosa  patient will receive leech therapy (1 to 4) consecutively for the period of three menstrual cycles on suprapubic region with each session lasting for a period of 45 minutes  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  females diagnosed with endometriosis with or without pelvic pain or secondary dysmenorrhea heavy menstrual bleeding
patients willing to participate in the trail by signing informed consent 
 
ExclusionCriteria 
Details  congenital malformation of the genital tract
pelvic malignancy
bleeding disorders
severe anaemia hb less than 8 gm
thrombocytopenia
lactation first 6 months
uncontrolled diabetes
uncontrolled hypertension
uncontrolled thyroid function 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
reduction in pain intensity assessed by visual analog scale  baseline
4 weeks
8 weeks
12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
overall reduction in severity of dysmenorrhea and associated symtoms assessed by WaLIDD
score
SF 12 QOL questionnaire will be used to assess the intensity of pain and quality of life
changes in usg for the size of endometriotic lesion 		 baseline
12 weeks
 
 
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   N/A 
Date of First Enrollment (India)   07/04/2026 
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="1"
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   Title: The effect of leech therapy in endometriosis an amphispective clinical study

Aim and Objectives: To evaluate the effect of leech therapy in endometriosis
                                 To assess the reduction and pelvic pain and dysmenorrhea following leech therapy in endometriotic patients
                                 To observe any changes in menstrual pattern and symptoms related to endometriosis after the treatment
                                 To compare retrospective and prospective clinical outcomes in patients who underwent leech therapy
                                 To document any adverse effects associated with leech therapy in endometriosis

Inclusion criteria: Reproductive age group women between 20 to 40 years 
                            Females diagnosed with endometriosis with or without pelvic pain or secondary dysmenorrhea , heavy menstrual bleeding 
                            Patients willing to participate in the trial by signing informed consent form
            
Exclusion criteria: Congenital malformation the genital tract 
                             Pelvic malignancy
                             Bleeding disorders
                             Severe anaemia hb less than 8 gm 
                             Thrombocytopenia
                             Lactation first 6 months
                             Uncontrolled diabetes mellitus ,hypertension ,thyroid function.

Sample Size : 30 

Intervention: Patients will receive leech therapy 1 to 4 leeches consecutively for a period of three menstrual cycle  at suprapubic region with each session lasting  for a period of 45 minutes.


Primary Outcome: Reduction of pain intensity will be assessed by VAS scale in each consecutive cycle

Secondary Outcome : Overall reduction in severity of dysmenorrhea and associated symptoms measured by WaLIDD score before and after intervention
                                   SF 12 QOL questionnaire will be used to assess the intensity of pain and quality of life.
                                   changes in USG for the size of endometriotic lesion.

                 
                      
 
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