To find the EFFECT of FEMIGARD GOLD in Menstrual Irregularities

Phase 2

Completed

• Conditions: Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle

• Registration Number: CTRI/2020/05/025435
• Lead Sponsor: Apex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-02-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

1.Female participants with;

i.Excessive menstrual bleeding

ii. Prolonged menstrual bleeding

iii. Presence of Blood clots in menstrual bleeding

iv. Recurrent Lower abdominal pain

v. Irregular menstrual cycle

vi. USG report suggestive of PCOS (Polycystic ovarian syndrome) and Uterine fibroid for group 1 & 2 respectively.

2. Subjects with stable vitals like pulse and blood pressure

3. Patient should have not participated in any other clinical trial during the past 3 months.

4. Proper written informed consent obtained from the participants before any procedure is performed.

Exclusion Criteria

1. Presence of any other Pelvic pathology

2. Presence of any other co morbid conditions like Diabetes mellitus and other cardiovascular complications.

3. Participants having IUCD(Intra uterine contraceptive device).

4. Presence of Thrombocytopenic purpura, Coagulopathy and any other bleeding complications.

5. Presence of severe Anemia ( <6 gm%)

6. Hypothyroidism

7. Pregnant or lactating women and with history of recent abortion.

8. Hypersensitivity to any of the components of the formulation.

9. Vulnerable population such as TB affected individuals, HIV and HBsAg positive patients.

10. Presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified