Health Condition 1: N948- Other specified conditions associated with female genital organs and menstrual cycle
Conditions
Interventions
Intervention1: Syrup Femigard gold.
: Composition:Each 15 ml has-
Asoka (saraca indica)500 mg, Lodhra (symplocos racemosa)300 mg, Ashwagandha (Withania somnifera)200 mg, Shunthi (Zingiber officinale)2
Sponsors
Apex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
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
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Regularization of menstrual cycle and flow at the end of 12 weeks. 2. Normalization or reduction of fibroid in group 2 - findings in ultrasonography (reduction in fibroid size) at the end of 12 weeks compared to baseline. 3. Hormonal assay (LH, FSH, Estradiol & Progesterone) at the end of 12 weeks treatment in PCOS patients of group 1. Timepoint: baseline and end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor for any adverse events during the study period [At end of 12 weeks (post study) of the study period, Complete blood count and Biochemical parameters will be repeated to assess the safety of the participants] and Assess the quality of life using a pre-and post-feedback questionnaire. Timepoint: Baseline and end of 12 weeks | — |
Countries
India
Contacts
Public ContactDr Ramesh Kannan
KI3, CRO (PM Medical centre)
Outcome results
None listed