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Clinical Trials/CTRI/2023/07/054875
CTRI/2023/07/054875Not yet recruitingPhase 2/3

A Clinical Study to evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara.

Shri Krishna Government Ayurvedic College and Hospital Kurukshetra1 site in 1 country40 target enrollmentStarted: July 27, 2023Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
1.To evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara.

Study Overview

Brief Summary

Any uterine bleeding outside the normal value, duration, regularity or frequency is AUB. Length of Rituchakra is lunar moon 28 days, normal menstrual interval is 21-35 days, duration of bleeding 3-5 days, amount is 50-80 ml. and change in any of the above parameters is known as Asrigdara. The word Asrigdara explains about prolonged, frequent or excessive menstrual bleeding in Ayurveda. The protocol in treating Asrigdara is to control the excessive bleeding and hence the drugs selected are of mainly madhura-tikta-kashaya rasa and sheeta virya which have Pitta shamaka and stambhaka properties. In our classical texts it is explained that Yoni  rogas do not occur without vitiation of Vata, thus first of all Vata should be normalized. So the selected drug will be given in the form of Basti which will help in pacifying Vata Dosha. Keeping all this in mind, this study has been designed to work out the clinical evaluation of effectiveness of Balaguduchyadi Taila matra basti in Asrigdara. There will be two groups of 20-20 patients in which Group A patients will be treated with Balaguduchyadi Taila matra basti. Group B patients will be treated with Tab Tranexamic Acid for three consecutive menstrual cycles. Follow up will be done after every cycle during trial for 3 months. After completing trial of 3 months, patients will be reassessed again after every menstrual cycle for 3 months to check the efficacy of trial drug.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Patients with either one or all symptoms of Asrigdara like Ritu Atipravitti (excessive bleeding during menstruation), Anritu pravritti (intermenstrual bleeding), Deergha Pravritti (prolonged bleeding).
  • Patients of reproductive, premenopausal age group.

Exclusion Criteria

  • Disease beyond the inclusive criteria.
  • Patients with uterine and pelvic pathology like fibroid, Ca cervix, cervical polyp etc.
  • Patients using intrauterine contraceptive device.
  • Patient with cardiovascular disease.
  • Patients with renal disease.
  • Patient having bleeding phase more than 15 Days.

Outcomes

Primary Outcomes

1.To evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara.

Time Frame: Duration of treatment: It will be given for 3 months. | Follow up: It will be done after every cycle during treatment & after treatment reassessment will be done for 3 months after every cycle.

2.Improvement in Signs & Symptoms of patients.

Time Frame: Duration of treatment: It will be given for 3 months. | Follow up: It will be done after every cycle during treatment & after treatment reassessment will be done for 3 months after every cycle.

3. Normalization of menstrual cycle.

Time Frame: Duration of treatment: It will be given for 3 months. | Follow up: It will be done after every cycle during treatment & after treatment reassessment will be done for 3 months after every cycle.

Secondary Outcomes

  • 1. Detailed study of Asrigdara by both ancient & modern view.(2. To find out an Ayurvedic approach for the management of Asrigdara.)

Investigators

Sponsor
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Sponsor Class
Other [Government Ayurvedic College]

Study Sites (1)

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