| CTRI Number |
CTRI/2023/09/057283 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study to evaluate the effect of kayaseka followed by daily purgation and immediate purgation in Rheumatoid arthritis |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of kayaseka followed by nitya virechana and sadyo virechana in amavata (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 |
Priyanka Kalal |
| Designation |
PG scholar |
| Affiliation |
Government ayurveda medical College Bangalore |
| Address |
Second year pg scholar Department of Panchakarma Government ayurveda medical college Dhanvantari road Banglore 09
Bangalore
KARNATAKA
560009
India |
| Phone |
9632383975 |
| Fax |
|
| Email |
priyankaskalal1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaila Bhorannavar |
| Designation |
Professor |
| Affiliation |
Government ayurveda medical College Bangalore 09 |
| Address |
Department of Panchakarma Government ayurveda medical college Dhanvantari road Banglore 09
Bangalore
KARNATAKA
560009
India |
| Phone |
8296634203 |
| Fax |
|
| Email |
shailaborannavar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaila Bhorannavar |
| Designation |
Professor |
| Affiliation |
Government ayurveda medical College Bangalore 09 |
| Address |
Department of Panchakarma Government ayurveda medical college Dhanvantari road Banglore 09
Bangalore
KARNATAKA
560009
India |
| Phone |
8296634203 |
| Fax |
|
| Email |
shailaborannavar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College Bangalore |
|
|
Primary Sponsor
|
| Name |
Priyanka Kalal |
| Address |
Second year pg scholar Department of Panchakarma Government Ayurveda Medical College Dhanvantari road Banglore 09 |
| 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 |
| Priyanka Kalal |
Shri jayachamarajendra ayurvedic hospital Bangalore |
OPD number 6ABC, Department of Panchakarma, Shri jayachamarajendra ayurvedic hospital Dhanvantari road Bangalore 09
Bangalore
KARNATAKA |
9632383975
priyankaskalal1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee , Government Ayurveda Medical College Bangalore |
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 | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka samhita , Procedure details: Kayaseka with Dashamoola kashaya for 7 days and sadyo virechana with Nimbamrutadi eranda taila on 8th day)
(1) Medicine Name: Vaishwanara churna , Reference: Chakradatta , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 3 Days(2) Medicine Name: Dashamoola Kashaya , Reference: Charaka samhita , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 5000(ml), Frequency: od, Duration: 7 Days(3) Medicine Name: Nimbamrutadi eranda taila , Reference: Astanga hrudaya , Route: Oral, Dosage Form: Taila, Dose: 90(ml), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka samhita , Procedure details: Kayaseka with Dashamoola kashaya followed by nitya virechana with Nimbamrutadi eranda taila for 8 days )
(1) Medicine Name: Vaishwanara churna , Reference: Chakradatta , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 3 Days(2) Medicine Name: Dashamoola Kashaya , Reference: Charaka samhita , Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 5000(ml), Frequency: od, Duration: 8 Days(3) Medicine Name: Nimbamrutadi eranda taila , Reference: Astanga hrudaya , Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged between 18-60 years of both genders.
2.Subjects fulfilling the diagnostic criteria of Amavata.
3.Subjects indicated for Kayaseka and Virechana.
|
|
| ExclusionCriteria |
| Details |
1.Subjects associated with uncontrolled Diabetes Mellitus, Hypertension, Cardiac diseases and other systemic disorders.
2.Rheumatoid arthritis patients with gross deformity.
3.Pregnant and lactating women.
• Patient with skin lesions, cuts, wounds |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sandhi shotha,sandhi shoola,sandhi stabdatha |
• Before starting treatment – on 0th day
• After completion of the treatment – on 8th day
• Follow up period - 24th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in CRP titer,RA factor titer & EULAR Score |
• Before starting treatment – on 0th day
• After completion of the treatment – on 8th day
• Follow up period - 24th day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/09/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Amavata is a aama pradoshaja vikara, caused by agnimandya, which leads to accumulation of ama in shleshmasthana and prakopa of vata dosha, resulting in angamarda, aruchi, trushna, alasya, gourav, jwara,apaka and shoonangata which closely resembles the rheumatological disorder called Rheumatoid arthritis.As Swedana and Virechana are two prime procedures mentioned in the chikitsa sutra of Amavata, the present study focuses on evaluating the effect of Kayaseka with Dashamoola kashaya followed by Nitya virechana and Sadyo virechana with Nimbamrutadi eranda taila in Amavata. |