| CTRI Number |
CTRI/2025/05/086197 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study how ayurvedic treatments (Vaitarana Basti and Pathyadi Churna) can help in patients of rheumatoid arthritis |
|
Scientific Title of Study
|
A Clinical Study on the
effect of Vaitarana basti and pathyadi churna in the management of Amavata w.s.r
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 KANJARIYA MANTHANKUMAR RAJESHBHAI |
| Designation |
MD(Ay.)SCHOLAR(PANCHAKARMA) |
| Affiliation |
GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,PATNA |
| Address |
DEPARTMENT OF PANCHAKARMA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,NEAR BUDDHA MURTI,KADAMKUAN,PATNA
Patna
BIHAR
800003
India |
| Phone |
8160663678 |
| Fax |
- |
| Email |
manthanrkanjariya99.39@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AKHILESH PRASAD SINGH |
| Designation |
GUIDE,ASSOCIATE PROFESSOR DEPARTMENT OF PANCHAKARMA |
| Affiliation |
GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,PATNA |
| Address |
DEPARTMENT OF PANCHAKARMA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,NEAR BUDDHA MURTI,KADAMKUAN,PATNA,BIHAR
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AKHILESH PRASAD SINGH |
| Designation |
GUIDE,ASSOCIATE PROFESSOR DEPARTMENT OF PANCHAKARMA |
| Affiliation |
GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,PATNA |
| Address |
DEPARTMENT OF PANCHAKARMA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,NEAR BUDDHA MURTI,KADAMKUAN,PATNA,BIHAR
Patna
BIHAR
800003
India |
| Phone |
8002680973 |
| Fax |
|
| Email |
drapsinghpatna@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,NEAR BUDHHAMURTI,KADAMKUAN,PATNA,BIHAR |
|
|
Primary Sponsor
|
| Name |
DR.KANJARIYA MANTHANKUMAR RAJESHBHAI |
| Address |
DEPARTMENT OF PANCHAKARMA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL,NEAR BUDHHAMURTI,KADAMKUAN,PATNA |
| Type of Sponsor |
Other [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 Kanjariya manthankumar Rajeshbhai |
Government Ayurvedic college and hospital near budhhamurti kadamkuan patna bihar |
Department of Panchakarma Government ayurvedic college and hospital near budhhamurti kadamkuan patna bihar
Patna
BIHAR |
8160663678
manthanrknjariya99.39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE(IEC) |
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 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Chakradatta Niruhadhikar Adhyaya 32, Procedure details: An application of Vaitarana basti for 15 days as Kala Basti on empty stomach in patients. )
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi CHurna, Reference: Bhaishajya ratnavali Amavata Chikitsa Adhyaya 21, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -ushnodaka), Additional Information: -Pathyadi churna given twice in Amavata after meal. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign & symptom of Amavata as mentioned in Madhav Nidan.
1)Both seropositive & seronegative cases of Aamavata.
2)Patients with age group of 20 to 70 years.
3)Patients with acute and less chronic duration of the disease. |
|
| ExclusionCriteria |
| Details |
Organ dysfunction and multiple chronic complications
1)Patients below 20 and above 70 year of age.
2)Patients in Gouty arthritis septic arthritis osteoarthritis and ankylosis spondylitis.
3)Patients having severe degree of deformity & complications, as per updravas described in
ayurvedic texts like Madhav Nidan.
4)Pregnancy and lactation
5)Chronicity more than 10yrs.
6)Patients with Hepatitis B (HBsAg) positive Hepatitis C positive and HIV Positive
Patients with COVID 19 Positive.
7)patients with psychological illnesses and patients who are not able or willing to sign
informed consent form. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in signs and symptoms of amavata.
1)Sandhi shoola(joint pain)
2)Sandhi shotha(joint swelling)
3)Sandhi stabdata(joint stiffness)
Anubandha Lakshana
4)Angamarda(body ache)
5)Aruchi(anorexia)
6)Trishna(thirst)
7)Alasya(laziness)
8)Jwara(fever)
9)Apaka(indigestion) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relief in
1)General function capacity
2)Walking time
3)Grip strength |
45 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)
|
15/05/2025 |
| 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="0"
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
|
This study is randomised open clinical trial to study about effect of Vaitarana basti and Shamana Aushadhi Pathyadi Churna in Amavata management with special reference to Rheumatoid arthritis in single group of 30 patients.This study will be held in Government Ayurvedic College and Hospital,patna,Bihar in the department of Panchakarma.After 15 days of intervention two follow up will be done at interval of 15 days for total duration of study about 45 days. |