| CTRI Number |
CTRI/2025/02/080553 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Churna] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of shatpushpadi churna and vaishwaner churna in Rhumatoid Arthritis disease |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to evaluate the efficacy of shatpushpadi churna with vaishwaner churna in alleviating the symptoms of Amavata 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 Sanghamitra Shivajirao Khope |
| Designation |
PG scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya,Amravati |
| Address |
OPD No.09,Kayachikitsa Department,Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati,Maharashtra.
Amravati
MAHARASHTRA
444605
India
Amravati
MAHARASHTRA
444605
India |
| Phone |
09370514909 |
| Fax |
|
| Email |
sanghamitrakhope6789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vaishali H Wankhade |
| Designation |
Guide and HOD Department oh Kayachikitsa |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya |
| Address |
OPD No.09,Kayachikitsa Department,Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati,Maharashtra.
Amravati
MAHARASHTRA
444605
India
Amravati
MAHARASHTRA
444605
India |
| Phone |
9420125432 |
| Fax |
|
| Email |
vaishalivhww@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanghamitra Shivajirao Khope |
| Designation |
PG scholar |
| Affiliation |
Vidarbha Ayurved Mahavidyalaya |
| Address |
OPD No.09,Kayachikitsa Department,Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati,Maharashtra.
Amravati
MAHARASHTRA
444605
India
Amravati
MAHARASHTRA
444605
India |
| Phone |
09370514909 |
| Fax |
|
| Email |
sanghamitrakhope6789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vidarbha Ayurved Mahavidyalaya and Hospital, Amravati,444605, India. |
|
|
Primary Sponsor
|
| Name |
Vidarbha Ayurved Mahavidyalaya |
| Address |
Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Sanghamitra Shivajirao Khope |
Vidarbha Ayurved Mahavidyalaya, Amravati. |
OPD No.09,Kayachikitsa Department,Vidarbha Ayurved Mahavidyalaya,Dhanvantari Nagar,Amravati,Maharashtra.
Amravati
MAHARASHTRA
444606
India
Amravati
MAHARASHTRA |
9370514909
sanghamitrakhope6789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.H.V.P.M. Vidarbha Ayurved Mahavidyalaya Amravati |
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. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vaishwaner Churna, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 43 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatpushpadi churna, Reference: Bhaishjya Ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 43 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject having age group 20 to 60 years irrespective of their sex, caste,marital status and economic class.
Patient will be selected as per classical symptoms of amavata.
Patient having RA FACTOR positive |
|
| ExclusionCriteria |
| Details |
Patients below 20 years and above 60 years of age.
Lactating and pregnant women.
Patient with evidence of malignancy.
Patients on chronic steroid usage.
Those suffering from any systemic illness like heart failure,dibetic mellitus,hepatic disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete remission from amavata(Arthritis)
Marked improvement in amavata(Arthritis)
Mild improvement in amavata (Arthritis).
Mild improvement in amavata(Arthritis). |
0th day
7th day
14th day
21th day
28th day
43th day
58th day
73th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sandhi shoola[joint pain]
Sandhi shotha[joint swelling]
Sandhi stabdhata[Morning stiffness]
Aruchi[Anorexia]
Jwara[Fever]
Vidvibandha[Constipation] |
43th day
58th day
73th day |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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
|
A Randomised controlled clinical trial to evaluate the effecacy of Shatpushpadi Churna and Vaishwaner Churna in Amavata with special reference to Rhumatoid Arthritis.
Tral will be conducted in our institute . Total 60 patients diagnosed with classical signs and symptoms of Amavata will be selected and then will be divided in two groups.
Shatpushpadi Churna will be given to one group and Vaishwaner Churna will be given to another one.
The study will be conducted for 60 days. Results will be compared in two groups. Data analysis will be done by using appropriate statistical test. Primary outcomes will be to study the effectiveness of Shatpushpadi Churna and Vaishwaner Churna in Amavata and complete, moderate and mild remission of Amavata in patients. |