| CTRI Number |
CTRI/2025/02/080282 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of management of Aaamvata with Erandadi kwath and Amritadi churna |
|
Scientific Title of Study
|
A comparative clinical evaluation of Erandadi kwath and Amritadi churna in the management of Aamvata with special reference 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 Roshani Singh |
| Designation |
M.D. Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda, IMS BHU Varanasi-221005 Uttar Pradesh I ndia
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7522832424 |
| Fax |
|
| Email |
roshanisinghims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajendra Prasad |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9411471910 |
| Fax |
|
| Email |
rajendraprasad051@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Rajendra Prasad |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda, IMS BHU Varanasi-221005 Uttar Pradesh I ndia
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9411471910 |
| Fax |
|
| Email |
rajendraprasad051@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Faculty of Ayurveda Institute of medical science, Banaras hindu university Varansi 221005 Uttar pradesh India |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Lanka Varanasi 221005 |
| 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 |
| Dr Roshani singh |
Sir Sundarlal Hospital |
OPD NO 21,22 Department of kayachikitsa, IMS BHU Varanasi 221005 UTTAR PRADESH
Varanasi
UTTAR PRADESH |
07522832424
roshanisinghims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadi churna , Reference: Bhaishjya ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandadi kwath, Reference: bhaisjya ratnawali 29/19, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to participate in the study.
2.Patients with age between 18-60 years. 3.The Patients of RA fulfills the diagnostic and assessment criteria, EULAR criteria
2010.
4.Both Seropositive and seronegative cases of RA.
5.Patients of both sexes.
6.Duration of illness at least 1-5 years.7.The patient with clinical feature of Aamvata mentioned in Samhita’s. Angamarda Aruchi Trishna Alasya
Gaurava Jwara Apaka Angasoonata. |
|
| ExclusionCriteria |
| Details |
1.Patients having severe ankylosed joints.
2.The patients of RA with major complications.
3.Patients of RA having other infective and non-infective joint disorders.
4.Patients with H/O less than 1 year and more than 5 years with established disease.
5.Patients having severe degree of deformity & complications.
6.Pregnant& lactating mother.
7.If patients having any allergy to the given drug.
8.Patients suffering from systemic disorder like (diabetes mellitus, cardiac disease,
pulmonary tuberculosis, Essential hypertension, SLE, infectious arthritis.) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in signs and symptoms of the disease. The
main signs and symptoms are follows:
stiffnes
lack of eating desire
fever
thirst
lethargy
swelling
heaviness in body and joints
indigestion |
3 Months with follow up at every 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in following-
1.On the basis of clinical sign and symptoms of grading scale
2.VAS scale
3.heamatological investigations(Anti ccp, RA factor, CBC, ESR,CRP,LFT,RFT
4.Assessment of severity of RA |
3 Months with follow up at every 1 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/02/2025 |
| 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 total 70 cases of Aamavata will be included in this study which will be randomly divided into 2 groups of 35 patients in each . one group will be prescribed Erandadi kwath ,one will be erandadi kwath with Amritadi churna. |