Study to Evaluate the safety and efficacy of Navroop- DS in patients suffering from Oligomenorrhea.

Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Navroop- DS in patients suffering from Oligomenorrhea. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/10/058629

Enrollment

Registered

2023-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: N915- Oligomenorrhea, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Females from 18 to 45 years of age. 2. Females suffering from Oligomenorrhea. 3. If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 4. Females that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study. 5. Females willing to avoid participation in any other interventional clinical trial for the duration of the study.

Exclusion criteria

Exclusion criteria: 1. Females that are pregnant, breast feeding, or planning to get pregnant during the study. 2. Females that have participated in any other interventional clinical trial in the previous 90 days. 3. Females with known sensitivity to any of the constituents of the investigational product.

Design outcomes

Primary

Measure	Time frame
Efficacy: •Change in the SGA Score (0-3) [Time frame 0-90 days] calculated as Abdominal Cramp, Headache, Vaginal discharge, Bloating, Irritability, Mood swings. •Change in the LH range within time frame 0-90 days. •Change in the FSH range within time frame 0-90 days. •Change in the LH/FSH Ratio range within time frame 0-90 days. Safety: •Adverse Events Tolerability of Navroop-DS syrup and tablet in treatment of Oligomenorrhea. Timepoint: [Time frame 0-90 days]	—

Measure

Time frame

Efficacy: •Change in the SGA Score (0-3) [Time frame 0-90 days] calculated as Abdominal Cramp, Headache, Vaginal discharge, Bloating, Irritability, Mood swings. •Change in the LH range within time frame 0-90 days. •Change in the FSH range within time frame 0-90 days. •Change in the LH/FSH Ratio range within time frame 0-90 days. Safety: •Adverse Events Tolerability of Navroop-DS syrup and tablet in treatment of Oligomenorrhea. Timepoint: [Time frame 0-90 days]

—

Secondary

Measure	Time frame
•Improvement in Quality of Life(SF-36)Timepoint: [Time frame 0-90 days]	—

Countries

India

Contacts

Public ContactPuneet Mittal

MGCTS(Mittal Global Clinical Trial Services)

puneetmittal@mgcts.org8937015757

Outcome results