| CTRI Number |
CTRI/2020/04/024876 [Registered on: 27/04/2020] Trial Registered Prospectively |
| Last Modified On: |
21/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A scientific study on Mritasanjeevana Rasa - an Ayurvedic medicine |
|
Scientific Title of Study
|
A Comparative Pharmaceutico-Analytical and Clinical study of Mritasanjeevana Rasa and its modified formulation on Amavata (Rheumatoid Arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMohar Pal Meena |
| Designation |
Associate professor |
| Affiliation |
National institute of Ayurveda |
| Address |
PG Department of Rasashastra and Bhaishajya Kalpana, National institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414564382 |
| Fax |
|
| Email |
moharpalmeena73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMohar Pal Meena |
| Designation |
Associate professor |
| Affiliation |
National institute of Ayurveda |
| Address |
PG Department of Rasashastra and Bhaishajya Kalpana, National institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414564382 |
| Fax |
|
| Email |
moharpalmeena73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVarad Charkha |
| Designation |
MD Scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
PG Department of Rasashastra and Bhaishajya Kalpana, National institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9404883311 |
| Fax |
|
| Email |
varadcharkha113@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jorawar Singh gate, Amer road, Jaipur, Rajasthan. PIN-302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Madhav Vilas Palace, Jorawar Singh gate, Amer road, Jaipur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVarad Charkha |
Arogyashala, National Institute of Ayurved |
OPD No.6, Department of Rasashastra and Bhaishajya Kalpana
Jaipur
RAJASTHAN |
9404883311
varadcharkha113@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
MRC |
Mritasanjeevana Rasa Classical (MRC)
Dose – 125 mg BD
Dosage form – Pills
Mode of administration – Oral
Duration – 28 days
Anupana – Water |
| Intervention |
MRM |
Mritasanjeevana Rasa Modified (MRM)
Dose – 125 mg BD
Dosage form – Pills
Mode of administration – Oral
Duration – 28 days
Anupana – Water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients present with classical signs & symptoms of Amavata.
Patients willing to give informed consent to participate for 28 days. |
|
| ExclusionCriteria |
| Details |
Patients present with systemic diseases like Diabetes mellitus, Cardiac Disease, Hypertension, etc.
Patients on prolonged ( > 6 weeks) medication with corticosteroids, etc. or any other drugs that may have an impact on the outcome of the study
Pregnant/lactating mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alteration in Disease Activity Score (DAS28) |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in signs and symptoms |
28 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2020 |
| 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="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amavata which resembles with Rheumatoid arthritis is a disease with high prevalence in middle age group, especially females. Rasashastra, pharmaceutical branch of Ayurveda provides potent and fast-acting medications against Amavata. This study aims at evaluating clinical efficacy of Mritasanjeevana Rasa (MRC) and its modified formulation (MRM) on Amavata (Rheumatoid Arthritis).
AIM
To comparatively evaluate clinical effect of MRC and MRM on Amavata (Rheumatoid Arthritis)
OBJECTIVES
1. To review literature on Mritasanjeevana Rasa.
2. To prepare classical formulation of Mritasanjeevana Rasa (MRC) and modified formulation of Mritasanjeevana Rasa (MRM)
3. To analyze the prepared samples of both formulations
4. To assess changes in signs and symptoms of Amavata
5. To assess changes in investigatory parameters
Null Hypothesis (H0) – There is no significant efficacy of MRC and MRM on Amavata.
Alternative Hypothesis (H1) – MRC and MRM are significantly effective on Amavata. |