Health Condition 1: N74- Female pelvic inflammatory disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Xanthium Strumarium Salt: The intervention being evaluated in this study is Xanthium Strumarium Salt , administered in the form of oral route. Participants in the intervention group wil
Sponsors
National Institute of Siddha
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of leiyomyoma through imaging. Diagnosis of uterine fibroid(s) documented by transvaginal or abdominal ultrasound at screening with at least 1 fibroid with largest diameter greater than or equal to 3.0 cm (For Adenomyosis GA11) Confirmed diagnosis of adenomyosis through imaging. Symptoms of pelvic pain or menorrhagia. (For Endometriosis-GA10) Confirmed diagnosis of endometriosis through imaging. Participants who have not undergone surgery for removing endometrial tissue within 9 months. Agree to withdraw usual analgesics for dysmenorrhoea, dyspareunia or Non Menstrual Pelvic pain if the pain is bearable.
Exclusion criteria
Exclusion criteria: Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) or Participants planning for pregnancy. Severe comorbidities or concurrent use of hormonal therapy or in the past three months. Hemoglobin values less than or equal to 5 g/dL or any condition requiring immediate blood transfusion (subjects with hemoglobin values less than or equal to 10.9 g/dL will be offered iron supplementation). (For Leiomyoma) o Uterine fibroid with largest diameter greater than 10.0 cm (For Endometriosis) History of pelvic malignancy Pelvic inflammatory disease (PID) Unable to undergo MRI for any reason (Metal implants, severe claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in pelvic pain severity using a standardized pain scale (e.g., Visual Analog Scale - VAS), comparing pre-treatment and post-treatment scores. Change in grade of ENZIAN classification of Endometriosis assessed by MRI from baseline to three to six months. Reduction in size of leiomyoma lesion from baseline to three to six months assessed by abdominal ultrasound/TVUS. Reduction in size and grading of adenomyosis through TVUS using MUSA grading of uterine lesions. To evaluate improvements in menstrual bleeding patterns by measuring changes in menstrual blood loss (e.g., using a pictorial blood loss assessment chart or menstrual blood loss assessment), number of bleeding days, and clinical severity of menorrhagia.Timepoint: By the end of third month | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate QoL changes using a validated tool such as the Endometriosis Health Profile30 (EHP-30) or the Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QOL) questionnaire, SF 36 questionnaire for adenomyosis focusing on physical, emotional, and social well-being. Timepoint: By the end of third month;Measure the change in serum CA-125 levels, a marker of endometriosis and adenomyosis, before and after treatment to assess disease activity.Timepoint: By the end of third month;Change in concentration of Oestradiol in Menstrual blood of willing patients before and after treatment of endometriosis and adenomyosis.Timepoint: By the end of third month;Change in monthly endometriosis associated pain scores of dysmenorrhea, dyspareunia and NMPP from baseline to each month till end point measured by the modified Biberoglu and Behrman scale (mBBS)Timepoint: By the end of third month;Change in adhesions from baseline to end point using TVUS.Timepoint: By the end of third month | — |
Countries
India
Contacts
Public ContactAmala Hazel
National Institute of Siddha
Outcome results
None listed