| CTRI Number |
CTRI/2023/06/054339 [Registered on: 22/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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 |
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Scientific Title of Study
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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 – An open label randomized controlled clinical study |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meera K Bhojani |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 302
3rd floor Academic Block
Dept of Kriya Sharir
All India Institute of Ayurveda
New Delhi
South
DELHI
110076
India |
| Phone |
9428570231 |
| Fax |
|
| Email |
meera.samhita@aiia.gov.in |
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Details of Contact Person
Scientific Query
|
| Name |
M Mahapatra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Head of the Department
Dept of Hematology
All India Institute of Medical Sciences
New Delhi
Central
DELHI
110608
India |
| Phone |
9868397233 |
| Fax |
|
| Email |
mrmahapatra@hotmail.com |
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Details of Contact Person
Public Query
|
| Name |
Anju Aravind T |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Dept of Kriya Sharir
All India Institute of Ayurveda
New Delhi
South
DELHI
110076
India |
| Phone |
6360305054 |
| Fax |
|
| Email |
anjuthapasya@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Ayurveda,Sarita Vihar
New Delhi |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda
Sarita Vihar
New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anju Aravind T |
All India Institute of Ayurveda in Association with AIIMS |
OPD NO. 8 In department of Kriya Sharir and integrative cancer OPD
South
DELHI |
6360305054
anjuthapasya@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D471||Chronic myeloproliferative disease. Ayurveda Condition: AMADOSHAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Musta, Reference: Sargdhara samhita, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 31.25(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: 31.25 gm of musta churna is boiled in 2L of water and reduced to 1L and will be used by the patient when the patient feels thirsty.
It will be add on to JAK 2 inhibitors 10mg BD | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Musta , Reference: Sargdhara samhita, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 31.25(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 6 Months, anupAna/sahapAna: Yes(details: -), Additional Information: -31.25 gm of musta churna is boiled in 2L of water and reduced to 1L and will be used by the patient when the patient feels thirsty.
This will be add on with Thalidomide 100 mg BD | | 3 | Comparator Arm (Non Ayurveda) | | - | Thalidomide | Dose 100mg BD
(Further decision for dosing during the course of study will be made by the principle investigator after clinical assessment of subject) | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Musta, Reference: Sargdhara samhita, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 31.25(g), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: 31.25 gm of musta churna is boiled in 2L of water and reduced to 1L and will be used by the patient when the patient feels thirsty.
This will be add on with Hydroxyurea 500mg BD | | 5 | Comparator Arm (Non Ayurveda) | | - | Ruxolitinib (JAK2 Inhibitor) | Dose of the drug will be decided on the basis of platelet count of enrolled subject, If subject is stable on 10 mg BID, it will be reduced by 50%. And the details of drug dose response during course of study will be recorded in case record form. | | 6 | Comparator Arm (Non Ayurveda) | | - | Hydroxyurea | Dose 500mg BD
(Further decision for dosing during the course of study will be made by the principle investigator after clinical assessment of subject) |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
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| ExclusionCriteria |
| Details |
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
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| Outcome |
TimePoints |
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 PMF |
180 Days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
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.
|
6 months |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Myeloproliferative Neoplasms include
three main entities: Polycythemia Vera (PV), Essential
Thrombocythemia (ET), and Myelofibrosis (MF). Primary
Myelofibrosis (PMF) is a type of neoplasm characterized with bone marrow
fibrosis. As per Ayurvedic texts Ama is an important concept, which can be
physiological or pathological. The main cause for Ama is improper functioning
of Agni. If it is physiological Ama, it will subside without taking any
medicines. If the Ama is not subsiding naturally, it requires certain medicine,
now it is pathological. If it is not properly treated, Amavisha develops in the
body, which can be compared with inflammatory markers. For this research,
validated questionnaire of Ama, Prakriti assessment using CCRAS Prakriti
assessment 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 of
the inflammatory markers before intervention. Then subjects will be assigned
into 6 groups based on symptoms and conventional treatments. Musta paneeya will
be given to subjects for 6 months in 3 groups out of 6 groups in addition to 3
types of conventional treatments and 3 groups will be taking conventional
treatments only (Thalidomide, JAK2 inhibitors, Hydroxyurea and supportive
therapy). Standard of care will be continued in all 6 groups. After 6 months of
intervention, 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 PMF
include; JAK2 inhibitors, Hydroxyurea and Thalidomide therapy. Success rate of these
conventional treatments are very low also. There is a current trend to take
herbal medicines along with conventional treatments. This highlights the
importance of Ayurveda in cancer management. The available
treatment methods are not sufficient to reduce the burden of disease. Here
comes the importance of integrative treatments. Integrative medical practice
requires good understanding of different medical systems and well-defined
treatment protocols in specific disease and its stages. This present study is
planned with following aims and objectives and integration in terms of ama pachana.
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