Role of Individualized Homoeopathic Medicine in 50 Millesimal Potencies in the Treatment of Acne Vulgaris: A Single Arm Pre-test Post-test Interventional Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Numerical pain rating scale (0-10)
Study Overview
Brief Summary
Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinisation, inflammation, and bacterial colonisation of hair follicles on the face, neck, chest, and back by Propioni bacterium acnes. Acne is estimated to affect 9.4% of the global population, making it the 8th most prevalent disease worldwide. From a homoeopathic perspective, skin diseases are the manifestations of an internal or constitutional disorder. Thus, the treatment of skin diseases is strictly based on constitutional criteria. Homoeopathy has produced few evidences in the treatment of Acne vulgaris. But the condition has not been researched yet using 50 millesimal potencies. Fifty millesimal potencies already having some evidences in treating acute or chronic diseases in its favour. Therefore, we shall undertake this study to explore the usefulness of individualized homoeopathic medicine in 50 millesimal potencies in the management of Acne vulgaris. In this study the homoeopathic medicines are administered orally, which are already known and safe for human use. all the patients will be prescribed individualized homoeopathic medicines in 50 millesimal potencies. Dosese and repetition will be as per homoeopathic principles. Outcomes will be Global Acne Grading System (GAGS) score, Dermatology Life Quality of Index (DLQI) score, measured at baseline and 3 months of treatment. The possible causal attribution will be evaluated by using Modified Naranjo Criteria for Homeopathy (MONARCH) Score, measured at the end of treatment in all cases (after 3 months of treatment).
Duration of therapy: 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
Inclusion Criteria
- •65 years. ii.Gender: Both Male and Female. iii.Diagnosed cases of Anal Fissure iv.Patients using topical agents for fissure will be included after a washout period of two weeks, subject to persistence of symptoms and signs of fissures v.Patient voluntarily giving written informed consent for the study.
Exclusion Criteria
- •i.Severe co-morbidities or any other uncontrolled systemic diseases, life-threatening illness etc.
- •affecting Quality of Life.
- •ii.Pregnant or breast-feeding women.
- •iii.Substance abuse and/ or dependence.
- •iv.Psychologically unstable patients.
- •v.Previous history of surgical interventions for anal fissure.
- •vi.Diagnosed or any suspected cases of rectal malignancies vii.Under-going homoeopathic treatment for any chronic diseases for last 3 months.
- •viii.Patients who are unable to read the patient information sheet and written consent form.
- •ix.Patient unwilling to take part in the study and not giving written consent for this study.
Outcomes
Primary Outcomes
Numerical pain rating scale (0-10)
Time Frame: Baseline and after 3 months.
Secondary Outcomes
- To evaluate the changes in scoring of HEMO-FISS scale
- Modified Naranjo Criteria for Homoeopathy (MONARCH)(After 3 months of treatment.)