A clinical trial to study the effects of two drugs,vati of rasanjan,laksha and aja ksheera and tablet progesterone in patients with heavy menstrual bleeding

Phase 2/3

Completed

• Conditions: Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH,

• Registration Number: CTRI/2023/04/051900
• Lead Sponsor: Tilak Ayurved Mahavidyalaya

Brief Summary

This is a randomised controlled clinical study to compare efficacy of vati of rasanjan,laksha and aja ksheera 500mg BD daily in comparison with tablet progesterone 5mg 1OD daily in the management of asrugdar(menorrhagia).Total number of patients is 56.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-30
• Study Completion: 2023-12-31
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

1 age group- 25-50 years 2 Increased number of bleeding days i.e more than 7days 3 Quantitave increase in menstrual blood i.e more than 80ml or more than 3 pads per day 4 Decreased intermenstrual period i.e lessthan 21 days 5 Fibroid uterus.

Exclusion Criteria

1 Traumatic bleeding 2 Post-menopausal bleeding 3 Cervical, uterine, ovarianneoplasm 4 Coagulopathy 5 Endometriosis 6 Bleeding through gravid uterus 7 Cervical polyp 8 Cervical erosion 9 Hyertensive Disorders, DM, Bleeding disorders, Cardiac diseases 10 Severe anemia( Hb < 8gm%) 11 HIV,HbsAg,VDRL,HPV positive 12 Congenital anomalies of genital tract 13 Patient requiring emergency management.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 To assess decrease in number of menstrual bleeding days	3 months
2 To assess quantitave decrease in menstrual bleeding	3 months
3 To assess relief in Katishool(lower abdominal pain)	3 months
4 Artavgrahitatwa(consistency presence of clots in menstrual blood)	3 months

Trial Locations

Locations (1)

Seth Tarachand Ramnath Charitable Ayurved Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Seth Tarachand Ramnath Charitable Ayurved Hospital

🇮🇳Pune, MAHARASHTRA, India

Priyanka Baliram Mutkule

Principal investigator

8766694989

mutkulepriyanka22@gmail.com