Clinical trial of NRL/WW/19-20 to promote health and wellbeing in woman

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 - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/06/025639

Enrollment

100

Registered

2020-06-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NRL/WW/19-20: NRL/WW/19-20 capsules 1 BD for 90 days Control Intervention1: Placebo: Placebo 1 BD for 90 days

Eligibility

Inclusion 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

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 Subjects with history of any acute or chronic illness that may affect the patientâ??s participation in the study Use of prescription medications and/or nonprescription medications for weight loss. Subjects with acute illness or history of major or minor surgery in the past one year. Female subjects who are currently pregnant and/or breast feeding Subjects not willing to participate in study. Subjects with history of hysterectomy, IUI and IVF or oral contraceptive pills (OCP) Subjects with PCOS and or on any hormone replacement therapy

Design outcomes

Primary

Measure	Time frame
Evaluation of menstrual distress using menstrual distress questionnaire Premenstrual/ menstrual pain assessment on VAS Daily energy levels Changes in hormonal profile- FSH, LH, Prolactin, Testosterone, Serum Insulin Anthropometric analysis HbA1c and glycaemic profile (blood sugar levels) Changes in skin, hair and nail health questionnaire reported by subjects hanges in skin, hair and nail health observed by physicianTimepoint: Baseline Visit ,Day 30 ,Day 60,Day 90	—

Measure

Time frame

Evaluation of menstrual distress using menstrual distress questionnaire Premenstrual/ menstrual pain assessment on VAS Daily energy levels Changes in hormonal profile- FSH, LH, Prolactin, Testosterone, Serum Insulin Anthropometric analysis HbA1c and glycaemic profile (blood sugar levels) Changes in skin, hair and nail health questionnaire reported by subjects hanges in skin, hair and nail health observed by physicianTimepoint: Baseline Visit ,Day 30 ,Day 60,Day 90

—

Secondary

Measure	Time frame
Quality of life (GHQ 9) Changes in mood behavior Safety profiling by LFT, RFT, TFT and lipid profile etc. Assessment of Overall Improvement by subject and investigatorTimepoint: Baseline Visit ,Day 30 ,Day 60,Day 90	—

Countries

India

Contacts

Public ContactDr Omkar Kulkarni

Netsurf Research Labs Pvt Ltd

omkar.kulkarni@nrl.net.in

Outcome results