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

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

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054339

Enrollment

Registered

2023-06-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D471- Chronic myeloproliferative disease

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects willing to participate & able to give informed consent 2. Newly diagnosed cases (Diagnosed within 3months and treatment naÃ¯ve) 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

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

Design outcomes

Primary

Measure	Time frame
1 Development and validation of Ama assessment tool 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 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	—

Measure

Time frame

1 Development and validation of Ama assessment tool 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 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

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Secondary

Measure	Time frame
1 Assessment of Prakruthi in patients of Primary Myelofibrosis & assess the Prakriti specific response to the intervention 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 3 To assess the in vitro drug interaction of musta with Hydroxyurea, JAK 2 inhibitors & Thalidomide. Timepoint: 6 months	—

Measure

Time frame

1 Assessment of Prakruthi in patients of Primary Myelofibrosis & assess the Prakriti specific response to the intervention 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 3 To assess the in vitro drug interaction of musta with Hydroxyurea, JAK 2 inhibitors & Thalidomide. Timepoint: 6 months

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Countries

India

Contacts

Public ContactAnju Aravind T

All India Institute of Medical Sciences

mrmahapatra@hotmail.com9868397233

Outcome results