Treatment of Excessive and prolonged bleeding during menstruation with Elaadi kwatha, Bola Baddha Rasa, Nagakesharaadi Churna

A Clinical study to correlate and diagnose different Abnormal uterine bleeding with Asrigdhara and to evaluate the cumulative effect of Elaadi kwatha, Bola baddha rasa and Nagakesharaadi churna in Asrigdhara

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044879

Enrollment

120

Registered

2022-08-24

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: N00-N99- Diseases of the genitourinary system

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Excessive bleeding during menstruation for more than two consecutive cycles 2. Duration of bleeding >5days 3. Amount of bleeding > 5 pads per day 4. Intervals between two menstrual cycles 5. Painful menstruation

Exclusion criteria

Exclusion criteria: 1. Vaginal bleeding caused by pregnancy and pregnancy related factors 2. Bleeding due to polycystic ovarian disease 3. Patient having Hemoglobin % 4. Thyroid dysfunction 5. Patient on hormone replacement therapy in last three months 6. Patient has intrauterine contraceptive device in situ 7. Submucosal fibroids >2cms in size / fibroids with uterine size > 12 weeks / with pressure symptoms 8. Post coital bleeding 9. Post menopausal bleeding 10. Genital tract malignancy 11. Sexually transmitted infections 12. Congenital malformations of female genital system 13. Patients suffering from bleeding disorders like hemophilia, DIC, Von Willebrand disease, ITP, Clotting factors deficiency like prothrombin, factor V,VII,X,XI and Acquired/ congenital platelet function defects 14. Patient taking anti- coagulants like heparin, warfarin, aspirin etc. 15. Systemic disorders like DM, HTN, Cardio vascular, cerebrovascular, Tuberculosis, Chronic kidney disorders, Cirrhosis of liver etc. 16. Patient on chemo/radiotherapy.

Design outcomes

Primary

Measure	Time frame
Sample size : 120 patients Asrigdhara (Abnormal uterine bleeding )with a prevalence rate of 17% in India. Statistics will be done based one- way repeated ANOVA test and Pearson correlation coefficient. Outcome of treatment: Ã¢â?¬Â¢ This alternative management which are safe, palatable, easy availability, cost effective, non-hormonal, without side effects and effective in normalization of menstrual flow. Ã¢â?¬Â¢ To reduce excessive, prolonged bleeding and associated symptoms during menstruation Timepoint: Each patient will be assessed 4 weeks once for 3 months and follow up every 4 weeks for 3 months.	—

Measure

Time frame

Sample size : 120 patients Asrigdhara (Abnormal uterine bleeding )with a prevalence rate of 17% in India. Statistics will be done based one- way repeated ANOVA test and Pearson correlation coefficient. Outcome of treatment: Ã¢â?¬Â¢ This alternative management which are safe, palatable, easy availability, cost effective, non-hormonal, without side effects and effective in normalization of menstrual flow. Ã¢â?¬Â¢ To reduce excessive, prolonged bleeding and associated symptoms during menstruation Timepoint: Each patient will be assessed 4 weeks once for 3 months and follow up every 4 weeks for 3 months.

—

Secondary

Measure	Time frame
This clinical study will improve quality life of female in terms of personal family social and work life The combination of medications Raktasthambhaka yogas can treat the condition effectively without surgical interventionTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Noor Fathima

Rajiv Gandhi University of Health Sciences, 4th Block, Jayanagar, Bangalore- 560041

mamath2@gmail.com09448215605

Outcome results