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

Double Blind Placebo Controlled Clinical Evaluation of Patented Natural Formulation with Special Reference to Menstrual Irregularities of various etiologies and women wellbeing

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055457

Enrollment

Registered

2023-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Changes in mood swing, better sleep and wellbeingTimepoint: at Entry and end of study i.e 8th week	—

Countries

India

Contacts

Public ContactDR B MISHRA

Sarvotham Care Ltd

srinur.y@sarvothamcare.com

Outcome results