Clinical Safety & Efficacy Evaluation of Botanical Ingredient Formulation with Special Reference to Menstrual Irregularities and Wellbeing of Women.

Phase 2

Conditions: Health Condition 1: N839- Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecifiedHealth Condition 2: N915- Oligomenorrhea, unspecified

Registration Number: CTRI/2023/07/055457

Lead Sponsor: SARVOTHAM CARE LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

i)Females aged between 18 to 45 years.

ii)Women with menstrual irregularity and anovulatory cycles, which may be associated with Infertility and PCOS .

iii)No past history of renal, hepatic, or any other chronic illness.

iv)Normal liver, and renal function tests.

v)Patients freely willing and able to provide written informed consent, willing to follow study procedures.

vi)Volunteers has no known history of allergy to both placebo and non-placebo group to be noted in CFR.

Exclusion Criteria

i)Any systemic pathologies like tuberculosis, uncontrolled Diabetes mellitus- Type I & suffering from malignant hypertension.

ii)Any genetic or congenital anomaly resulting in amenorrhoea and oligomenorrhoea.

iii)Any recent medical or surgical illness including malignancies and premature menopause or surgical menopause or secondary longer amenorrhea.

iv)Not willing to sign the informed consent and not committed for regular follow ups cooperating the clinical evaluation and having a planned pregnancy during the study process.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Evaluation of menstrual regularities in terms of frequency, flow and change of pads. <br/ ><br>2.Evaluation of discharge per vagina in terms of color, smell and stickiness to undergarments. <br/ ><br>3.Evaluation of women wellbeing psychometric assessment, evaluated by trained psychologist. <br/ ><br>4.Evaluation of change in follicular count, and size. <br/ ><br>5.Improvement in metabolic profile like Blood glucose and insulin levels, cholesterol, triglycerides, HDL and LDL <br/ ><br>Timepoint: at entry and end of study i.e. 8th week

Secondary Outcome Measures