Health Condition 1: L501- Idiopathic urticaria
Conditions
Interventions
None listed
Sponsors
Ayurveda and Unani Tibbia college and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals confirmed according to symptoms of Sheetapitta explained in the ayurvedic texts (Laghuttrayi) 2. Individuals of any gender aged 16-70 years. 3. Participants with UAS7 scores between greater than or equal to 3 and less than 27 at baseline will be included to ensure measurable disease activity and meaningful outcome assessment((based on UAS7 scale ranging from 0 to 42, in which less than 27 is severe and greater than 28 is very severe)
Exclusion criteria
Exclusion criteria: 1. Populations with skin diseases other than Urticaria 2. Cutaneous infection or any infection requiring treatment within 1 week before the screening visit 3. Patients taking long time steroid and anti-histaminic medications (more than 6 months). 4. Patients with comorbid conditions such as known cases of Diabetes mellitus (Fasting blood sugar greater than 126mg/dl), Grade 2 hypertension (BP greater than 160/100mmhg), Renal impairment (Sr. creatinine greater than 1.2 mg/dl), Hepatic impairment (SGOT and SGPT is three times the upper limit). 5. Subjects with comorbidities such as Tuberculosis, immunocompromised states such as HIV, history or active malignancy, history of cardiovascular disease, etc. 6. Pregnant women and lactating mothers. 7. Patients having angioedema and other serious complications of Urticaria requiring urgent medical attention. 8. Subjects having hypersensitivity to any of the trial interventions or their ingredients 9. Currently participating or participated in any other study of a drug, within the past 6 months before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in severity of symptoms of Sheetapitta as mentioned in Ayurvedic texts (Laghuttrayi). 2.Proportion of participants having Equal to or Greater than 50 percent or more improvement in UAS (Urticaria Activity Score) UAS7 scores. Timepoint: Day 0, Follow up on 7 days initially on Day7,Day14,Day21,Day28, Follow up every 15 days on Day 43,Day 58,Day 73,Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum IgE, CRP & AEC as a marker of allergic inflammation.Timepoint: Day 0, Day 90 at the end of trial;Proportion of participants achieving Equal to or Greater than 4 point reduction in DLQI (Dermatology Life Quality Index).Timepoint: Day 0, Day 90 at the end of trial;Changes in parameters LFT, KFT & CBC as a measure of safety profile.Timepoint: Day 0, Day 90 at the end of trial | — |
Countries
India
Contacts
Public ContactDr SUJATA YADAV
Ayurveda and Unani Tibbia College and Hospital
Outcome results
None listed