| CTRI Number |
CTRI/2026/02/105006 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improvement of severe period pain with leech therapy. |
|
Scientific Title of Study
|
The effect of medicinal leech therapy on the improvement of dysmenorrhea an open labelled 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 Husna Begum |
| Designation |
Pg scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
OPD room no 8 Pg Department of Gynaecology and Obstetrics Government Nizamia Tibbi College and General hospital
Charminar Hyderabad T.G
Hyderabad
TELANGANA
500059
India |
| Phone |
9052200325 |
| Fax |
|
| Email |
husnab454@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Suhasini |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
PG Department Of Gynaecology and Obstetrics Government Nizamia Tibbi College
Charminar Hyderabad T.G
Charminar Hyderabad T.G
Hyderabad
TELANGANA
500002
India |
| Phone |
9949586899 |
| Fax |
|
| Email |
drasuhasini12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Husna Begum |
| Designation |
Pg scholar |
| Affiliation |
Government Nizamia Tibbi College |
| Address |
OPD room no 8 PG Department of Gynaecology and Obstetrics Government Nizamia Tibbi College and General Hospital
Charminar Hyderabad T.G
Hyderabad
TELANGANA
500002
India |
| Phone |
9052200325 |
| Fax |
|
| Email |
husnab454@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital Charminar Hyderabad T.G 500002 India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College |
| Address |
Charminar Hyderabad T.G
500002 |
| Type of Sponsor |
Government medical college |
|
|
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 Husna Begum |
Government Nizamia Tibbi College and general hospital |
OPD room no 8
PG Department of Gynaecology and Obstetrics
Hyderabad
TELANGANA |
9052200325
husnab454@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee Government nizamia tibbi college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N946||Dysmenorrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
medicinal leech [Hirudinaria granulosa] |
patient will receive leech therapy [2 leeches] 4 days prior to the onset of menstruation based on the individual cycle in three consecutive menstrual cycle on the suprapubic region with each session lasting 30 to 45 minutes |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
patient with primary and secondary dysmenorrhea |
|
| ExclusionCriteria |
| Details |
Congenital malformation of the genital tract
Pelvic malignancy
Bleeding disorders like anaemia less than 7 gm per dl
Thrombocytopenia
Pregnancy
Lactation upto 6 months
Hypertension
Patient on anticoagulants
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in pain intensity assessed by Visual Analogue Scale in each consecutive cycle |
Baseline day 0
4 weeks
8 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall reduction in severity of dysmenorrhea & associated symptoms measured by WaLIDD Score |
Baseline day 0
4 weeks
8 weeks
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="49"
Sample Size from India="49"
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 3 |
|
Date of First Enrollment (India)
|
12/03/2026 |
| 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="6"
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
|
Dysmenorrhea is the most common gynaecological complaint in adolescent and young women which incapacitates day to day activities , which includes pelvic and non pelvic pathologies.Title of the study : The Effect of Medicinal Leech Therapy on the improvement of Dysmenorrhea An Open Labelled Study
Aim : To assess the effect of medicinal leech therapy on the improvement of dysmenorrhea.
Inclusion Criteria : Female patients in the age group of 16 to 40 years with primary and secondary dysmenorrhea.
Exclusion Criteria : The following patients will be excluded from the study 1.Age below 16 and above 40 years 2.Hypertension 3.Patients on anticoagulants 4.Congenital malformation of the genital tract 5.Pelvic malignancies 6.Pregnancy and lactation (upto 6 months) 7.Bleeding disorders like severe anaemia and thrombocytopenia
Sample size : 49
Intervention :Patient will receive leech therapy (2 leeches) at the supra pubic region prior to the onset of menstruation based on the individual cycle for three consecutive cycles with each session lasting 30 minutes or until the leeches detaches spontaneously.
Outcomes : Primary outcome : reduction in pain intensity assessed by VAS Scale Secondary outcome overall reduction in severity of dysmenorrhea and associated symptoms assessed by WaLIDD Score.
|