Medication for improving quality of life in women with abdominal pain

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/059190
• Lead Sponsor: Dr Sweta Singh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-11
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients with subjective symptoms.
• Patients willing to comply with the treatment.
• Patients not received any hormonal treatment in 2 cycles prior.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS score	0 and 3 months

Secondary Outcome Measures

Name	Time	Method
Biberoglu and Behrman score (B&B)	WHO Quality of Life Questionnaire (WHOQOL-BREF)

Trial Locations

Locations (1)

AIIMS Bhubaneswar; 🇮🇳 Khordha, ORISSA, India

AIIMS Bhubaneswar

🇮🇳Khordha, ORISSA, India

Dr Sweta Singh

Principal investigator

9438884131

obgyn_sweta@aiimsbhubaneswar.edu.in