| CTRI Number |
CTRI/2023/03/050329 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
02/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
To know the effect of guggulu and churna in the management of Amavata w.s.r. to Rheumatoid Arthritis |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of vatari guggulu and shatpushpadi churna with simhanada guggulu in the management of amavata w.s.r. to 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 |
Professor Anjana Mishra |
| Designation |
M.D. ( ayu.) kayachikitsa department |
| Affiliation |
RGGPG AYURVEDIC COLLEGE PAPROLA H.P.. |
| Address |
Department of kayachikitsa room number 215 Rajiv Gandhi Govt Post Graduate Ayurvedic college Kangra HIMACHAL PRADESH 176115 INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Anjana Mishra |
| Designation |
M.D. ( AYU) kayachikitsa department |
| Affiliation |
RGGPG AYURVEDIC COLLEGE PAPROLA H.P.. |
| Address |
Department of kayachikitsa room number 215 Rajiv Gandhi Govt Post Graduate Ayurvedic college Kangra HIMACHAL PRADESH 176115 INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani |
| Designation |
PG Scholar |
| Affiliation |
RGGPG AYURVEDIC COLLEGE PAPROLA H.P.. |
| Address |
kayachikitsa department rajiv gandhi govt post graduate ayurvedic college and hospital paprola kangra HIMACHAL PRADESH 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
6230405596 |
| Fax |
|
| Email |
thakurshivani9974@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola District Kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayrvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayrvedic College and Hospital Paprola District Kangra Pin Code 176115 |
| 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 |
| Professor Anjana Mishra |
Rajiv ghandhi govt post graduate ayurvedic college and hospital paprola |
Department of kayachikitsa room number 215 Rajiv Gandhi Govt Post Graduate Ayurvedic college Kangra HIMACHAL PRADESH 176115 INDIA
Kangra
HIMACHAL PRADESH |
09418312324
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (Human) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhanada guggulu, Reference: Chakardutt Aamvatadhikar/29-34, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vatari guggulu, Reference: Bhaishajya ratnavali 29/149-151, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Shatpushpadi churna, Reference: Chakradutta amavatadhikara /21, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing for study
Age group 30-70 years will be selected for the study
Patients with signs and symptoms of Amavatar wsr. to Rheumatoid Arthritis as described in classical texts and fulfill the diagnostic criteria.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing for the study.
2. Patients below age of 30 years and above 70 years of age.
3. Patients suffering from cardiac, respiratory, P.T.B. Malignancy, Patient already taking chemotherapy, radiotherapy. Pregnant and Lactating women. Allergy to the research drug or any other condition considered to be Unfit for enrollment in the trial. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in symptoms of amavata after intervention of vatari guggulu and shatpushpadi churna with simhanada guggulu
Morning stiffness
Generalised body aches
Reduced appetite
Thirst
Lethargy
Indigestion
Joints pain
Constipation
Disturbed sleep
Burning sensation
Nausea
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving quality of life |
6 Weeks |
|
|
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 4 |
|
Date of First Enrollment (India)
|
10/03/2023 |
| 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="0"
Months="6"
Days="0" |
|
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)?
Response - NO
|
|
Brief Summary
|
Pateints will be selected from faculty/OPD of RGGPG Ayurvedic College and Hospital , Paprola . Two groups of 15 pateints will be selected on the basis of inclusion and exclusion criteria . Interventional drug will be given to both groups of patient to know the effect of Guggulu and churna |