To evaluate the safety and efficacy of Endotone polyherbal capsule in treatment of Endometriosis.

Phase 4

Not yet recruiting

Conditions: Endometriosis, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,

Brief Summary: Endometriosis is a prevalent disease estimated to affect 10% of women of reproductive age, upto 50% of women with pelvic pain, and 20%-50% of women with reduced fertility. The commonest symptom is pelvic pain, which presents as dysmenorrhea in over 98% of patients with symptomatic endometriosis and non-menstrual pelvic pain. Pelvic pain associated with endometriosis varies greatly in intensity, frequency and duration from patient to patient. Non-menstrual pelvic pain is usually chronic (lasting â‰¥ 6 months), and it can be intermittent throughout the menstrual cycle or continuous and may present as dull, throbbing, or sharp pain. In addition, the pain related to endometriosis has been shown to impair both work- related and non-work-related daily activities.

For the present study, a polyherbal formulation manufactured by Charak Pharma Pvt. Ltd. will be taken up for the study. The formulation has been standardized after formulating SOPs along with acute toxicity study. The objective of current study is to assess clinical safety and efficacy of the study drug in symptoms associated with endometriosis.

Recruitment & Eligibility

Inclusion Criteria

1. Female 18 to 45 years of age (inclusive) at the time of screening. 2) Women experiencing endometriosis symptoms like pelvic pain, dysmenorrhea, Dyspareunia 3) Women with documented diagnosis of endometriosis by either of the following.
a) Laparoscopy or laparotomy b) VAS test score of 1-7 for dysmenorrhea/dyspareunia and/or Pelvic pain due to endometriosis. c) Clinical features, pelvic examination findings d) Diagnosed case of endometriosis by any radio-imaging techniques. 4) Recurrent Endometriosis after surgery.

Exclusion Criteria

1. Participant having chronic pelvic pain that is not caused by endometriosis 2) Patients with concomitant hormonal treatment, including oral contraceptive pills.
3)Patients with known systemic diseases (e.g., hypertension, diabetes, coronary, renal, and hepatic diseases).
1. Patients with known malignancy.
1. Menopausal women, Pregnancy, Lactating women.
1. Large chocolate cysts.

Primary Outcome Measures

Name	Time	Method
Pain reduction in endometriosis	3 months

Secondary Outcome Measures

Name	Time	Method
Improved quality of life.	6 Months

Locations (1): Sunflower Womenâ€™s Endo Infertility Hospital Pvt Ltd,
🇮🇳
Ahmadabad, GUJARAT, India
Sunflower Womenâ€™s Endo Infertility Hospital Pvt Ltd,
🇮🇳Ahmadabad, GUJARAT, India
Dr Ratibhai Patel
Principal investigator
9662512070
drrgpatel@sunflowerhospital.in