| CTRI Number |
CTRI/2022/02/040534 [Registered on: 23/02/2022] Trial Registered Prospectively |
| Last Modified On: |
22/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A Clinical Study of Alambushadi Churna and Shatyadi Kashay in patients of Amvata vis a vis Rheumatoid Arthritis" |
|
Scientific Title of Study
|
"A Clinical Study of Alambushadi Churna and Shatyadi Kashay in patients of Amvata vis-a-vis 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 |
Dr Priyanka Yadav |
| Designation |
Ph.D Scholar |
| Affiliation |
Shri krishna Ayush University Kurukshetra Haryana |
| Address |
Room no. 55 56 first floor
Department of Kayachikitsa Shri krishna Ayush University Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
7054236800 |
| Fax |
|
| Email |
pinkdeep55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Balbir Singh |
| Designation |
Professor & Head |
| Affiliation |
Shri Krishna Ayush University Kurukshetra |
| Address |
Room no. 55 56 first floor
Department of Kayachikitsa Shri krishna Ayush University Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9813063424 |
| Fax |
|
| Email |
balbirsandhu63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annada Prasad Nayak |
| Designation |
Associate Professor |
| Affiliation |
MSM Institute of Ayurveda Khanpur Kalan Sonepat Haryana |
| Address |
MSM Institute of Ayurveda BPS Mahila Viswavidyalya Khanpur Kalan Sonipat Haryana
Sonipat
HARYANA
131305
India |
| Phone |
09355506222 |
| Fax |
|
| Email |
vd_apnayak@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Ayush University Kurukshetra Haryana |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Shri Krishna Ayush University Kurukshetra Haryana |
| Address |
Shri Krishna Ayush University Kurukshetra Haryana
PIN 136118 |
| 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 |
| Dr Priyanka yadav |
MLR ayurveda college and Hospital |
Room no 7 Kayachikitsa OPD RK Gupta Marg College road Charkhi Dadri Haryana 127306
Bhiwani
HARYANA |
7054236800
pinkdeep55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shri Krishna Ayush University,Kurukshetra, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M95-M95||Other disorders of the musculoskeletal system and connective tissue. Ayurveda Condition: Amvata, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Alambushadi Churna, Reference: Bhaisjya Ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatyadi Kashay, Reference: Bhaisjya Ratnawali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group between 30-50 years willing to participate for the trial with a diagnosis of rheumatoid arthritis using theEULAR diagnostic criteria
Diagnosed cases of Amavata based on symptoms and signs described in MadhavNidana.
3. Seropositive and Seronegative both cases are included.
4. Having history of less than 5 years. |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate.
2. Patients having severe deformities.
3. Patients of Gouty Arthritis, Infective Arthritis, Osteoarthritis.
4. HIV, Tuberculosis, Hypertension, D.M., and other major systemic problems.
5. Pregnant & lactating women
6.Patients with major complications such as extra articular manifestations like leg ulcers, digital gangrene, Episcleritis, Endocarditis, pleural and pericardial effusions, neurological and haematologic manifestations etc. will also be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ï‚·Both the drugs of the study are expected to be effective because these are mentioned specifically in Amvataprakran in classical text and all constituents are having properties opposite to Ama dosha Vedanashamak and Shothhara |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ï‚·there can be significant reduction in modern objective parameters like RA factor Anti CCP CRP So effect of Ayurvedic text formulations on Modern parameters can be proved by the study |
45 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Randomized parallel trial with title " A Clinical Study Of Alambushadi churna and Shatyadi Kashay in patients of Amvata vis-a-vis Rheumatoid Arthritis" in which 100 patients will be taken under 2 groups. Group A consists of Alambushadi Churna 5 gms with lukewarm water BD for 45 days .Group B contains Alambushadi Churna 5gm BD and Shatyadi Kashay 40 ml BD for 45 days. Follow up period is of 15 days.The components of Alambushadi Churna are Alambusha Gokshura Haritaki Bhibhitak Amlaki Shunthi Amrita and Shyama root. Shatyadi Kashay consists of Shati Shunthi Ativisha Vacha Devdaru Guduchi in equal parts. Patient assessment will be done on the basis of subjective and objective criteria and diagnosis according to EULAR criteria.
|