Health Condition 1: D899- Disorder involving the immune mechanism, unspecified
Conditions
Interventions
Intervention1: Thymosin alpha one: Thymosin alpha 1 with a dose 3.2 mg will be given to patient subcutaneous twice a week for a period of 3 Months
Control Intervention1: SOC: SOC will be administered
Sponsors
Gufic Biosciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients between the age group =18and = 49 years of age at the time of consent 2. Patients with a confirmed diagnosis of Endometriosis (up to stage III) based on laparoscopy or imaging 3. Patients having negative urine pregnancy test at the time of screening and agree to the use of barrier contraception during the study period 4. Patients who are willing to comply with study procedures and restrictions 5. Patients who can and are willing to provide signed informed consent
Exclusion criteria
Exclusion criteria: 1. Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial ablation resulting in amenorrhea 2. Candidate for elective gynaecological surgery [Dilation and Curettage (D&C), cervical cryosurgery, colposcopy, Loop Electrosurgical Extension Procedure (LEEP)] for next 6 months 3. Patient who had a normal or C section delivery with a gap of less than 3 months after cessation of Lactation 4. Participation in other clinical trials in last three months and during study period 5. Patients having an unstable medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study outcomes 6. Patients having a history of positive human immunodeficiency virus antibody (HIV Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab) assay at Screening or have a history of a positive result 7. Pregnant and lactating female lactating at the time of screening and willing to continue lactating during the study 8. Any other condition, which as per the investigator would jeopardize the outcome of the trial 9. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the efficacy of Thymosin a 1 in combination with SOC versus SOC alone in patients with endometriosis in terms of endometriosis associated pain assessed by a Visual Analogue Scale (VAS) scoreTimepoint: Day -2, Day 1, Day 30, Day 45, Day 60, Day 90, Day 135, Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate and compare the efficacy of Thymosin a 1 in combination with SOC versus SOC alone in patients with endometriosis in terms of Dysmenorrhea (DYS) pain scale score, Dyspareunia (DYSP) pain scale score, Non-Menstrual Pelvic Pain (NMPP) pain scale, lower back pain, dyschezia related pain on NRS, and overall size of Endometriosis. • To assess and compare the safety of Thymosin a 1 in combination with SOC versus SOC alone.Timepoint: Day 1, Day 30, Day 60, Day 90, Day 135 and Day 180 | — |
Countries
India
Contacts
Public ContactVairamuthu Ammaiyappan
Gufic Biosciences Limited
Outcome results
None listed