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Clinical Trials/CTRI/2020/06/025639
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
etsurf Communications Pvt Ltd

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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