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