Develop a tool for assessment of poor metabolic activities and to assess the level of inflammatory markers before and after giving Musta (Cyperus rotundus) hot infusion in Primary myelofibrosis
Phase 2
- Conditions
- Health Condition 1: D471- Chronic myeloproliferative disease
- Registration Number
- CTRI/2023/06/054339
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Development and validation of Ama assessment tool <br/ ><br>2 Assessment of status of ama lakshana before and after taking ama pachana medicine- Musta paneeya (Cyperus rotundus Linn) as add to conventional treatments in patients with PMF <br/ ><br>3 Assessment of inflammatory markers at molecular level before and after taking ama pachana medicine- Musta paneeya (Cyperus rotundus Linn) as add to conventional treatments in patients with PMFTimepoint: 180 Days
- Secondary Outcome Measures
Name Time Method 1 Assessment of Prakruthi in patients of Primary Myelofibrosis & assess the Prakriti specific response to the intervention <br/ ><br>2 Assessment the quality of life of patients of Primary Myelofibrosis after taking amapachana medicines- Musta paneeya (Cyperus rotundus Linn) as add on to the conventional treatments in patients of Primary Myelofibrosis <br/ ><br>3 To assess the in vitro drug interaction of musta with Hydroxyurea, JAK 2 inhibitors & Thalidomide. <br/ ><br>Timepoint: 6 months