CTRI/2023/06/054339
Not yet recruiting
Phase 2
Study to develop a validated tool for the assessment of ama, and to assess the effect of amapachana medicines - Musta (Cyperus rotundus Linn.) as add on to conventional treatments in patients of Primary Myelofibrosis and the expression of inflammatory markers at molecular level â?? An open label randomized controlled clinical study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: D471- Chronic myeloproliferative disease
- Sponsor
- All India Institute of Ayurveda
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects willing to participate \& able to give informed consent
- •2\.Newly diagnosed cases (Diagnosed within 3months and treatment naïve) of Primary Myelofibrosis
- •3\.JAK2 V617 mutation positive (Annexure 5\)
- •4\.Symptomatic and requiring treatments
- •5\.Eligible for treatment with either of JAK2 inhibitors, Hydroxyurea or Thalidomide
Exclusion Criteria
- •1\.Psychiatric patients on treatment
- •2\.Patients with co\-morbidities like Hypertension, DM etc
- •3\.Pregnant women and lactating mothers
- •4\.Who are unable to take oral medications
- •5\.SRSF2, ASXL1, and U2AF1\-Q157 mutations
- •6\.3 times increased creatinine levels than the normal
- •7\.Hb less than 8g/ dl
- •8\.Leucocytes greater than 25\.10(9\)/L
- •9\.Esophageal varices, bleeding, Ascites
Outcomes
Primary Outcomes
Not specified
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