Clinical trial of NRL/WW/19-20 to promote health and wellbeing in woma
- Registration Number
- CTRI/2020/06/025639
- Lead Sponsor
- etsurf Communications Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of menstrual distress using menstrual distress questionnaire <br/ ><br>Premenstrual/ menstrual pain assessment on VAS <br/ ><br>Daily energy levels <br/ ><br>Changes in hormonal profile- FSH, LH, Prolactin, Testosterone, Serum Insulin Anthropometric analysis <br/ ><br>HbA1c and glycaemic profile (blood sugar levels) <br/ ><br>Changes in skin, hair and nail health questionnaire reported by subjects <br/ ><br>hanges in skin, hair and nail health observed by physicianTimepoint: Baseline Visit ,Day 30 ,Day 60,Day 90
- Secondary Outcome Measures
Name Time Method Quality of life (GHQ 9) <br/ ><br>Changes in mood behavior <br/ ><br>Safety profiling by LFT, RFT, TFT and lipid profile etc. <br/ ><br>Assessment of Overall Improvement by subject and investigatorTimepoint: Baseline Visit ,Day 30 ,Day 60,Day 90