Evaluation Of Effectiveness Of Lodhra-Vacha-Dhanyak Gel As Topical Application In Yuvan-Pidika (Acne Vulgaris)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- After the study, we anticipate being able to showcase the effectiveness of
Study Overview
Brief Summary
Acne Vulgaris is a chronic inflammatory skin condition that primarily affects young individuals, with an estimated 85% of those aged 12-25 experiencing it, as reported by the Global Burden of Disease Study 2019. The condition is driven by the bacteria Propionibacterium acneand Staphylococcus epidermidisand presents with both non-inflammatory and inflammatory lesions, including comedones, papules, nodules, and cysts.In Ayurveda*, Acharya Sushruta* first described this condition as Yuvan-Pidika under the classification "Kshudraroga," noting its connection to the vitiation of Kapha, Vata, and Rakta, which leads to eruptions resembling Shalmali kantak. This understanding aligns closely with the symptoms of Acne Vulgaris. Ayurvedic remedies for Yuvan-Pidika, such as a paste made from Lodhra (Symplocos racemosa), Vacha (Acorus calamus), and Dhanyak (Coriandrum sativum), have been documented by various scholars as effective treatment.
This study is a single-blind, randomized controlled clinical trial aimed at evaluating the effectiveness of Lodhra-Vacha-Dhanyak gel in treating Yuvan-Pidika (Acne Vulgaris). A total of 60 patients, aged 12-30yrs, will be randomly selected using a simple random sampling technique and divided into two groups of 30.
- Group A (Trial Group) will apply Lodhra-Vacha-Dhanyak gel evenly to the entire facial area twice daily for 45 consecutive days after washing their face.
- Group B (Placebo Control Group) will apply a water-based gel in the same manner for the same duration.
The diagnosis of Yuvan-Pidika will be based on the presence of facial eruptions (Pidika). The study will take place at Pt. Khushilal Sharma Govt. Ayurveda College & Hospital, Bhopal (M.P.). The goal is to demonstrate that Lodhra-Vacha-Dhanyak gel can provide a safe, natural, accessible, and cost-effective treatment option for Acne Vulgaris.
Study Design
- Study Type
- Interventional
- Allocation
- Adaptive randomization, such as minimization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 12.00 Year(s) to 30.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Unmarried subjects of 12-30 yrs of the age group of either sex, irrespective of their religion, caste, or race will be included.
- •2.Subjects affected by Acne Vulgaris exclusively on their facial region.
- •3.Subjects willing to sign the informed consent form and are ready to stop any other specific acne treatment.
Exclusion Criteria
- •1.Subjects with acne vulgaris affecting areas other than the face, such as the chest and back.
- •2.Subjects with any other dermatological condition.
- •3.Subjects who are exposed to sunlight for extended periods.
- •4.Known cases of hormonal disorders or undergoing steroid therapy or hormone replacement therapy.
- •5.The subject presents with cysts, abscesses, and widespread scarring across the face.
- •6.Known cases of serious systemic diseases.
Outcomes
Primary Outcomes
After the study, we anticipate being able to showcase the effectiveness of
Time Frame: 45 Days
management option.
Time Frame: 45 Days
Lodhra-Vacha-Dhanyak gel in the treatment of Yuvan-Pidika (Acne Vulgaris). This
Time Frame: 45 Days
treatment approach could offer a safe, natural, readily accessible, and cost-effective
Time Frame: 45 Days
Secondary Outcomes
- N/A(N/A)