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 2/3

Not yet recruiting

Conditions: Chronic myeloproliferative disease. Ayurveda Condition: AMADOSHAH,

Registration Number: CTRI/2023/06/054339

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: Myeloproliferative Neoplasms includethree main entities: [Polycythemia Vera](https://www.sciencedirect.com/topics/medicine-and-dentistry/polycythemia-vera "Learn more about Polycythemia Vera from ScienceDirect’s AI-generated Topic Pages") (PV), [EssentialThrombocythemia](https://www.sciencedirect.com/topics/medicine-and-dentistry/essential-thrombocythaemia "Learn more about Essential Thrombocythemia from ScienceDirect’s AI-generated Topic Pages") (ET), and [Myelofibrosis](https://www.sciencedirect.com/topics/medicine-and-dentistry/myelofibrosis "Learn more about Myelofibrosis from ScienceDirect’s AI-generated Topic Pages") (MF). PrimaryMyelofibrosis (PMF) is a type of neoplasm characterized with bone marrowfibrosis. As per Ayurvedic texts Ama is an important concept, which can bephysiological or pathological. The main cause for Ama is improper functioningof Agni. If it is physiological Ama, it will subside without taking anymedicines. If the Ama is not subsiding naturally, it requires certain medicine,now it is pathological. If it is not properly treated, Amavisha develops in thebody, which can be compared with inflammatory markers. For this research,validated questionnaire of Ama, Prakriti assessment using CCRAS Prakritiassessment tool and QoL assessment tool will be applied on individuals with PMF.These will be ELISA test, Allele burden test and blood tests for assessment ofthe inflammatory markers before intervention. Then subjects will be assignedinto 6 groups based on symptoms and conventional treatments. Musta paneeya willbe given to subjects for 6 months in 3 groups out of 6 groups in addition to 3types of conventional treatments and 3 groups will be taking conventionaltreatments only (Thalidomide, JAK2 inhibitors, Hydroxyurea and supportivetherapy). Standard of care will be continued in all 6 groups. After 6 months ofintervention, all the 6 groups will be assessed with CBC including ESR and CRP,ELISA test, Allele burden, QoL tool and Ama assessment questionnaire.

Three main types of treatments of PMFinclude; JAK2 inhibitors, Hydroxyurea and Thalidomide therapy. Success rate of theseconventional treatments are very low also. There is a current trend to takeherbal medicines along with conventional treatments. This highlights theimportance of Ayurveda in cancer management. The availabletreatment methods are not sufficient to reduce the burden of disease. Herecomes the importance of integrative treatments. Integrative medical practicerequires good understanding of different medical systems and well-definedtreatment protocols in specific disease and its stages. This present study isplanned with following aims and objectives and integration in terms of *ama pachana*.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

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

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
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	180 Days
1 Development and validation of Ama assessment tool	180 Days
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 PMF	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	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

Trial Locations

Locations (1): All India Institute of Ayurveda in Association with AIIMS
🇮🇳
South, DELHI, India
All India Institute of Ayurveda in Association with AIIMS
🇮🇳South, DELHI, India
Anju Aravind T
Principal investigator
6360305054
anjuthapasya@gmail.com