CTRI/2020/06/025639
Not yet recruiting
Phase 2
Randomized, placebo controlled clinical trial to assess the efficacy and safety of NRL/WW/19-20 to promote health and wellbeing in woman in fertile age - NI
etsurf Communications Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- etsurf Communications Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Fertile Women Aged 18 \- 50 years
- •BMI in the range of 20\-26 Kg/m2 should be incorporated
- •With or without painful menstruations for at least three consecutive cycles with regular menstrual cycles having normal bleeding phases (21\-35 days)
- •Not associated with any organic reproductive system abnormalities (excluded clinically and radiologically as per history)
- •Subjects having good physical condition and sound mental status.
- •In the judgment of the Principal Investigator, able to comply with protocol requirements.
- •Subjects willing to sign written informed consent Willing to abstain from use of additional vitamin or mineral supplements, nutritional supplements and or medical foods if applicable.
Exclusion Criteria
- •Subjects with uncontrolled diabetes and diabetes with renal dysfunction.
- •Cases of secondary dysmenorrhea
- •Abdominal pain associated with excessive vaginal bleeding
- •Known cases of ovarian cysts endometriosis
- •Associated with pelvic inflammatory diseases (PID Hydrosalpinx)
- •History of malignancy of pelvic organs
- •History of hypo and hyper thyroidism
- •Uncontrolled Hypertensive subjects
- •Presence of any major illness such as cancer, heart disease, COPD, Asthma etc.
- •Subjects with medical history of any major illness such as cancer, heart disease, COPD, Asthma etc. in the past
Outcomes
Primary Outcomes
Not specified
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