A Randomized controlled clinical study to evaluate the efficacy as Antimicrobial, Anti inflammatory & healing effect of Mahagouradya Ghrita in the management of Dushta Vrana
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Antimicrobial, anti inflammatory and healing effect of Mahagouradya Ghrita as local application for 28 days in Dushta Vrana
Study Overview
Brief Summary
Ulcer management is emerging as a specialty branch. Ayurveda has described various Kalpas in Samhitas. So, with the new era, Ayurveda can contribute by its wide range of medicaments in ulcer healing. But the management of Vranas, particularly Dusta Vranas (non healing ulcers) is still a challenge for surgeons.
Therefore in the present study, all efforts are first aimed at keeping the Vrana clean during the various stages of its healing.
For the present study, Mahagouradya Ghrita described in Gadanigraha prayogkhand ghrutadhikar will be applied on Dushta Vrana for its management.
Mahagouradya Ghrita contains Gouri (Daruharidra), Nisha, Manjishtha, Jatamansi, Katurohini (Kutaki), Prapoundarik, Yashtimadhu, Bhadramusta (Nagaramotha), Raktachandan, Jatiphala, Nimba, Patola, Karanja Beeja, Katphal, Madhucchishta, Panchavalkal, Ghrita and Kshir. It is mentioned as SarvaVranavishodhana and Vranaropana.
The contents are easily available and are cost effective.
The goal of study is to increase our understanding of antimicrobial, anti inflammatory and healing effect of Mahagouradya Ghrita.
Primary Objective:
To study the effect of Mahagouradya Ghrita as local application for 28 days as antimicrobial, anti inflammatory and healing in Dushta Vrana on the basis of Pus/Slough culture and Tissue cytology.
Secondary Objective:
To study comparison of Mahagouradya Ghrita as local application and Cadaxomer iodine ointment as local application for 28 days as antimicrobial, anti inflammatory and healing effect in Dushta Vrana on the basis of Pus/Slough culture and Tissue cytology.
Hypothesis:
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Alternate Hypothesis H1(a)– Mahagouradya Ghrita is effective as antimicrobial, anti inflammatory and healing in the management of Dushta Vrana.
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Alternate Hypothesis H1(b)- Mahagouradya Ghrita is more effective than Cadaxomer iodine ointment as antimicrobial, anti inflammatory and healing in the management of Dushta Vrana.
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Null Hypothesis H0– Mahagouradya Ghrita is not effective as antimicrobial, anti inflammatory and healing in the management of Dusta Vrana.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with signs and symptoms of Dushta Vrana.
- •Patients with Dushta Vrana and have controlled diabetes and hypertension.
- •Patients ready to give written consent.
- •Size of Vrana up to 8cm x, 5cm x, 1cm (Twakamansa sthit Dushta Vrana).
- •Dusht Vrana of 1month to 1 year.
- •Patients 18yrs to 70yrs of age.
- •Subjects included irrespective of sex and economic status.
Exclusion Criteria
- •Ulcer with other disorders e.g. H.I.V, hepatitis etc, Malignant ulcers, Tubercular ulcers, Syphlitic ulcers, Leprosy, Martorels hypertensive ulcers and Patient having history of bleeding disorders.
- •Patients having embolism, bleeding disorder, arterial occlusion disease other infective skin disorders.
- •Ulcer having excessive loss of tissues.
Outcomes
Primary Outcomes
Antimicrobial, anti inflammatory and healing effect of Mahagouradya Ghrita as local application for 28 days in Dushta Vrana
Time Frame: At Day 1,7,14,21,28
Secondary Outcomes
- To compare the Antimicrobial, anti inflammatory and healing effect of Mahagouradya Ghrita and Cadaxomer iodine ointment local application for 28 days in Dushta Vrana.(28 Days)