| CTRI Number |
CTRI/2023/10/059190 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Medication for improving quality of life in women with abdominal pain |
|
Scientific Title of Study
|
Allopurinol for improving the quality of life in endometriosis: a randomized controlled trial |
| 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 Sweta Singh |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Room No 409, Academic Block, All India Institute of Medical Sciences, Bhubaneswar-751019, Odisha.
Khordha
ORISSA
751019
India |
| Phone |
9438884131 |
| Fax |
|
| Email |
obgyn_sweta@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta Singh |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Room No 409, Academic Block, All India Institute of Medical Sciences, Bhubaneswar-751019, Odisha.
Khordha
ORISSA
751019
India |
| Phone |
9438884131 |
| Fax |
|
| Email |
obgyn_sweta@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srirameena V |
| Designation |
Postgraduate resident |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Room No 409, Academic Block, All India Institute of Medical Sciences, Bhubaneswar-751019, Odisha.
Khordha
ORISSA
751019
India |
| Phone |
9442414567 |
| Fax |
|
| Email |
drsrirameena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 409
Academic Block
All India Institute of Medical Sciences Bhubaneswar 751019, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Sweta Singh |
| Address |
Room No 409, Academic Block, Department of Obstetrics and Gynaecology, AIIMS Bhubaneswar |
| Type of Sponsor |
Other [Self] |
|
|
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 Sweta Singh |
AIIMS Bhubaneswar |
Room No 409,
Department of Obstetrics and Gynaecology
Khordha
ORISSA |
9438884131
obgyn_sweta@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Allopurinol |
Tab Dienogest 2 mg once daily plus Tab Allopurinol 300mg once daily for three months |
| Comparator Agent |
Placebo |
Tab dienogest 2 mg once daily plus multivitamin tablet once daily for three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients with subjective symptoms.
Patients willing to comply with the treatment.
Patients not received any hormonal treatment in 2 cycles prior. |
|
| ExclusionCriteria |
| Details |
Patients with known allergy or hypersensitivity to one or both of the drugs.
Patients who are pregnant or lactating.
Patients taking part in any other clinical trials.
Patients with active sexually transmitted infections.
Patients with any coexisting chronic disease
Patients with routine consumption of analgesics for reasons other than endometriosis.
Patients with undiagnosed abnormal genital bleeding.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score |
0 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Biberoglu and Behrman score (B&B)
WHO Quality of Life Questionnaire (WHOQOL-BREF)
Patient Health Questionnaire (PHQ-9)
Female Sexual Function Inventory (FSFI)
|
0 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
06/11/2023 |
| 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) |
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
|
Endometriosis is a chronic inflammatory condition affecting women in the reproductive age group. It is often debilitating and limits the quality of life in affected women. Oxidative stress is widely accepted as a mechanism for disease development and progression. Anti-oxidants have been thus tried to mitigate the symptoms. Allopurinol is anti-oxidant and has been tried in a variety of diseases with an inflammatory etiology. However, there are no randomized studies of allopurinol in women with endometriosis. Thus, the aim of this study will be to evaluate whether treatment with allopurinol allevates the symptoms of endometriosis and improves the quality of life when given in addition to the standard of care i.e. dinogest. |