| CTRI Number |
CTRI/2025/08/092395 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Surgery and Medicines for Pain Relief and Nerve Function in Women with Endometriosis |
|
Scientific Title of Study
|
Comparison of the effects of surgical and pharmacological treatment on AFT, HRV, and NPRS in endometriosis patients: A prospective longitudinal 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 |
Vishnu Balram |
| Designation |
Undergraduate Medical Student |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Nehru B and C Block Hostel
Kasturba Medical College
Manipal Academy of Higher Education
Madhav Nagar
Manipal-576104
Udupi District
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7306202908 |
| Fax |
|
| Email |
vishnu332005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishnu Balram |
| Designation |
Undergraduate Medical Student |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Nehru B and C Block Hostel
Kasturba Medical College
Manipal Academy of Higher Education
Madhav Nagar
Manipal-576104
Udupi District
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7306202908 |
| Fax |
|
| Email |
vishnu332005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishnu Balram |
| Designation |
Undergraduate Medical Student |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Nehru B and C Block Hostel
Kasturba Medical College
Manipal Academy of Higher Education
Madhav Nagar
Manipal-576104
Udupi District
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7306202908 |
| Fax |
|
| Email |
vishnu332005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Kasturba Medical College
Manipal Academy of Higher Education(MAHE)
Madhav Nagar
Manipal-576104
Udupi District
Karnataka |
| Type of Sponsor |
Private 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 |
| Vishnu Balram |
Kasturba Hospital |
Department of Physiology, Clinical autonomic lab, 2nd floor, physiology building, Madhav nagar
Manipal Academy of Higher Education, manipal
Udupi
KARNATAKA |
7306202908
vishnu332005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Instituitional Ethics comittee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients willing to undergo either surgical or pharmacological treatment.
2. Patients with no prior treatment for endometriosis within the past 6 months.
|
|
| ExclusionCriteria |
| Details |
1. Patients with comorbid systemic diseases (e.g., diabetes, hypertension).
2. Pregnant or lactating women.
3. Patients with a history of psychiatric disorders or autonomic dysfunction.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the changes in AFT among endometriosis patients’ surgical and pharmacological treatment groups.
2. To evaluate the HRV variations between the surgical and pharmacological treatment groups.
3. To compare NPRS scores to determine the efficacy of pain management in the two groups.
|
1. Baseline
2. 12 weeks after initiation of treatment plan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare NPRS scores to determine the efficacy of pain management in the two groups.
|
1. Baseline
2. 12 weeks after initiation of treatment plan |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
18/08/2025 |
| 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 Yet Recruiting |
| 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
|
This prospective longitudinal study aims to compare the effects of surgical and pharmacological treatment on autonomic function tests (AFT), heart rate variability (HRV), and numerical pain rating scale (NPRS) outcomes in women with endometriosis. Endometriosis, a chronic and painful gynecological condition, is often managed through either surgical intervention (laparoscopy) or pharmacological therapy (hormonal agents), but their comparative effects on physiological and pain-related outcomes are underexplored.
Ninety-two women aged 18–45 years, newly diagnosed with endometriosis and opting for either surgery or medical management, will be recruited. Participants will undergo baseline assessments for AFT, HRV, and NPRS, with follow-up evaluations at 1 month post-treatment. The study will not involve randomization; treatment decisions will be based on patient preference and clinical judgment.
Statistical analysis will include t-tests, ANOVA, and regression modeling to assess changes in autonomic function and pain perception between groups. The study aims to provide evidence-based insights into how different treatment modalities influence pain relief, autonomic balance, and overall physiological recovery, thus guiding personalized treatment strategies for women with endometriosis. |