Clinical study on the efficacy of Guduchi Ghrita as shamananga snehapana in the management of Ekakushta (Plaque Psoriasis): A controlled clinical study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Reduction in the clinical signs and Symptoms of Ekakushta based on
Study Overview
Brief Summary
A controlled clinical study on the efficacy of Guduchi ghrita as shamananga snehapana in the management of Ekakushta (Plaque Psoriasis) in adults of age group 18-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Ekakushta (Plaque Psoriasis) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group)15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Guduchi ghrita internally as shamananga snehapana in the dose of 30ml in the morning 20mins before breakfast followed by ushnajala pana along with Nalpamaradi taila as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Panchatiktaka guggulu ghrita internally as shamananga snehapana in the dose of 30ml in the morning 20mins before breakfast followed by ushnajala pana along with Nalpamaradi taila as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. The primary outcome measure will be significant improvement noticed in Psoriasis area and severity index score (PASI) of Psoriasis after 30 days. The secondary outcome measure will be improvement noticed in the quality of life of the patient through Dermatological quality of life questionnaire after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient of age group 18 to 60 years fulfilling diagnostic criteria.
- •2.Patients irrespective of gender ,religion, socioeconomic status, 3.Patients with clinical features of Ekakushta or Plaque psoriasis.
Exclusion Criteria
- •1.Subjects those who are unfit for Snehapana.
- •2.Subjects with Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Psoriatic arthritis.
- •4.Pregnant and Lactating Women.
- •5.Subjects age below 18 and above 60 years.
- •6.Subjects with Psoriasis having secondary severe infections.
- •7.Subjects with other than Plaque psoriasis.
Outcomes
Primary Outcomes
Reduction in the clinical signs and Symptoms of Ekakushta based on
Time Frame: Oth day (Baseline),15th day,30th day and 45th day
1.Psoriasis area and Severity index score
Time Frame: Oth day (Baseline),15th day,30th day and 45th day
Secondary Outcomes
- Significant improvement noticed in the Quality of life of patient and reduction in signs and symptoms of Ekakushta based on Dermatological quality of life questionnaire(Baseline,15th day,30th day and 45th day)
Investigators
Dr Pooja Prakash Chougala
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital ,Bangalore