| CTRI Number |
CTRI/2025/02/080860 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study to see effect of Punarnavadi churna over Ajmodadi Churna in the management of Aamvata with reference to Rheumatoid Arthritis |
|
Scientific Title of Study
|
A randomized controlled clinical study of efficacy of Punarnavadi Churna and Ajmodadi Churna in the management of Aamvata W.S.R to Rheumatoid Arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trushagni Omprakash Dudhe |
| Designation |
MD Kaychikitsa Scholar (Ayurveda) |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyalaya,Patur,Akola |
| Address |
OPD no 3 Department of Kayachikitsa Dr.VJD Gramin Ayurved Mahavidyalaya,near Renukamata mandir, balapur road, Patur Tal-Patur,Dist-Akola pin 444501
Akola
MAHARASHTRA
444501
India |
| Phone |
9359653887 |
| Fax |
|
| Email |
trushagnidudhe2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Katole |
| Designation |
Professor and Head of the Department,Kayachikitsa |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyalaya |
| Address |
opd no department of kaychikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renukamata mandir, balapur road, Patur Tal-Patur,Dist-Akola pin 444501
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Katole |
| Designation |
Professor and Head of the Department,Kayachikitsa |
| Affiliation |
Dr.VJD Gramin Ayurved Mahavidyalaya |
| Address |
opd no department of kaychikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renukamata mandir, balapur road, Patur Tal-Patur,Dist-Akola pin 444501
Akola
MAHARASHTRA
444501
India |
| Phone |
9423847608 |
| Fax |
|
| Email |
drjrkatole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of KayachikitsaDr.VJD Gramin Ayurved Mahavidyalaya,Patur,Dist-Akola,Maharashtra,India pin code-444501 |
|
|
Primary Sponsor
|
| Name |
DrVJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr.VJD Gramin Ayurved Mahavidyalaya near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola,Maharashtra,India
Pin code 444501 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrTrushagni Dudhe |
Dr.VJD Gramin Ayurved Mahavidyalaya |
OPD NO.3,Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,dist-Akola
Akola
MAHARASHTRA |
9359653887
trushagnidudhe2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee,Gramin Ayurved Mahavidyalaya,Patur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnavadi Churna, Reference: Bhaishajya Ratnavali Aamvatadhikar 41,42, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ajamodadi Churna, Reference: Sharangdhar Samhita Dvitiya khand Adhyay 6 /120,122, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients willing for clinical trial
2-Patients having sign and symptoms of Aamvata
3-The patients age group 20 to 60 years
4-Patients will be selected irrespective of sex and religion
5-RA test positive patients |
|
| ExclusionCriteria |
| Details |
1-Patients not willing for clinical trial
2-Patients age not less than 20 years and more than 60 years
3-Chronicity more than 5 years
4-Any severe deformity
5-Pregnant women, Lactating mothers
6-Any major illness like HIV,AIDS,TB,HTN,DM and other malignancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like-1.Sandhishool Pain
2.Sandhishoth Inflammation
3.Sandhistabdhata
4.Sandhi sparshasahatva will be decreased and control over Aamvata with reference to Rheumatoid Arthritis. |
15 days,30 days,45 days,after starting the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Aamvata and control over RA value. |
18 months |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| Ayurveda is a science of life.It has so many treasures of life that make men disease free healthy and long living. Main objective of the science is to maintain the health of healthy and curing the ailments of ailing. Aamvata is the most common inflammatory joint disorder throughout the world. Aamvata voice recognised as a separate disease only in late 9th century A.D. when Madhavakar describe the distinct etiopathogenesis and symptomatology for it and coined the term Aamvata. Aamvata has been in ayurvedic text into references. a) to indicate vitiation of vayu with Aam dosha. b) indicate a disease term as Aamvata Roga a constitutional disorder with clinical manifestation of joint inflammation. Vitaited Aam and Vayu by involves koshtha (GIT) ,Trika(L.S.Spines) and sandhi joints creates pain in joints, loss of appetite, indigestion, stiffness of joint ,swelling of joints, weakness and heavyness in chest this condition is known as aamvata. In 21st century rheumatoid arthritis has been more common and distressing among all joints problem. About 0.8% of world population is affected by rheumatoid arthritis. Females are three times more affected than male. It is a chronic employment disease of joint with multi system environment. The onset is usually during 4th and fifth decade of life. However people of any group can be affected in any climate rheumatoid arthritis make affected person unfit for an independent life. The changing lifestyle of human being by means of dietatic and behaviour pattern place a major role in manifestation of several disorders. Thus this type of pattern may also lead to the development of the | disease Aamvata. |