A Comparative Clinical Trial to Evaluate the effect of Triphaladi Guggulu vati and Varun Shigru vati in patient of garbhasya arbuda(rasouli)

Phase 2

Completed

• Conditions: Health Condition 1: N85- Other noninflammatory disorders ofuterus, except cervix

• Registration Number: CTRI/2021/03/032198
• Lead Sponsor: State Ayurvedic College and Hospital lucknow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Patient having symptoms of uterine fibroid.

2.Fibroid size less or equal to 5 cm as per usg report(single or multiple fibroid).

3.Patient willing to participate in this trial therapy.

Exclusion Criteria

1.Patient below the age of 20 and above the age of 45 years.

2.Patient having fibroid size >5cm as per usg report.

3.Fibroid in pregnancy.

4.Fibroid with severe menstrual disturbance like metrorrhagia, menometrorrhagia, polymennorrhea etc.

5.Woman with Hb <8 gm %.

6.Patient using IUCD or taking OC pills.

7.Patient suffering from any other organic pathology like ovarian tumor, tubo-ovarian mass, endometriosis, PID, malignancy etc.

8. Patient suffering from any systemic illness which may be deteriorate her general health like HTN, DM, TB, Cardiac disorder, Thyroid dysfunction etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the effect of Triphaladi guggulu vati and varun shigru guggulu vati in the management of Garbhashaya arbud w.s.r. uterine fibroid. <br/ ><br>2. To assess the trial drug on subjective parameters like menorrhagia, dysmenorrhea, dyspareunia, pain and heaviness in lower abdomen, backache, frequent urination, constipation and objective parameter are Hb%,TLC,DLC, ESR, Platelet count, CT,BT,USG(lower abdomen).Timepoint: Final assessment will be done after completion of trial of 4 month.

Secondary Outcome Measures

Name	Time	Method
To assess the trial drug on subjective parameters like menorrhagia, dysmenorrhea, dyspareunia, pain and heaviness in lower abdomen, backache, frequent urination, constipation.Timepoint: Follow up - every month during trial.