| CTRI Number |
CTRI/2024/10/074794 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Virechana Karma with Kashmaryadi Kashaya and Eranda Taila in Vatarakta(Gouty Arthritis) |
|
Scientific Title of Study
|
A comparative clinical evaluation of Virechana Karma with Kashmaryadi Kashaya and Eranda Taila in Vatarakta(Gouty 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 |
Akansha Singh |
| Designation |
Pg Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
Panchakarma Department opd no 4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7088292573 |
| Fax |
|
| Email |
singh.akansha290598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Mahajan |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan evum Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
Panchakarma Department opd no 4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9760376761 |
| Fax |
|
| Email |
shivani.mahajan@divyayoga.com |
|
Details of Contact Person
Public Query
|
| Name |
Akansha Singh |
| Designation |
Pg Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan evum Anusandhan Sansthan Haridwar Uttarakhand |
| Address |
Panchakarma Department opd no 4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7088292573 |
| Fax |
|
| Email |
singh.akansha290598@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar Uttaranchal
Pin code 249405
India |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan |
| Address |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand
Pin code 249405
India |
| Type of Sponsor |
Private 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 |
| Akansha Singh |
Patanjali Ayurvigyan evum Anusandhan Sansthan |
opd no.4 panchakarma department
Hardwar
UTTARANCHAL |
7088292573
singh.akansha290598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M258||Other specified joint disorders. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka Samhita Chikitsasthana 29/85, Procedure details: (Procedure Reference: Charaka Chikitsa Sthana 29/83, Procedure details: POORVA KARMA: Langhana & Deepana – Pachana with Chitrakadi Vati is given till the Niram Lakshna. Abhyantara Snehapana was carried out by Shunthi Ghrita in increasing dose starting from 30 ml. PRADHANA KARMA: After proper Snehana – Swedana, patients will be administered with Virechana Yoga on empty stomach. Kashmaryadi Kashaya with a minimum dose of 100ml will be given. According to Kostha, age & sex of patient dose may be increased. Virechana yoga with sufficient quantity of Ushnajala as Anupana will be given to the patients in the morning hours in between 9:30–10:00 AM. Then Shuddhi Lakshana in terms of Laingiki, Vaigiki, Antiki, & Manki will be assessed. PASCHAT KARMA: After the successful completion of Virechana, the patients will be asked to follow all the precautions related to Virechana. Samsarjana Krama will be given as per type of Shuddhi Lakshana and in sequence mentioned by classics.)
(1) Medicine Name: Kashmaryadi Kashaya, Reference: Charaka Samhita Chikitsasthana 29/85, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka Samhita Chikitsasthana 29/85, Procedure details: POORVA KARMA: Langhana & Deepana – Pachana with Chitrakadi Vati is given till the Niram Lakshna. Abhyantara Snehapana was carried out by Shunthi Ghrita in increasing dose starting from 30 ml. PRADHANA KARMA: After proper Snehana – Swedana, patients will be administered with Virechana Yoga on empty stomach. Eranda Taila with a minimum dose of 60ml will be given. According to Kostha, age & sex of patient dose may be increased. Virechana yoga with sufficient quantity of Ushnajala as Anupana will be given to the patients in the morning hours in between 9:30–10:00 AM. Then Shuddhi Lakshana in terms of Laingiki, Vaigiki, Antiki, & Manki will be assessed. PASCHAT KARMA: After the successful completion of Virechana, the patients will be asked to follow all the precautions related to Virechana. Samsarjana Krama will be given as per type of Shuddhi Lakshana & in sequence mentioned by classics.)
(1) Medicine Name: Eranda Taila, Reference: Charaka Samhita Chikitsasthana 29/83, Route: Oral, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient present with clinical features of Vatarakta.
1.Patient of either sex between age group of 18 to 60 years. 2.Patients were selected irrespective of sex, occupation, socio economic status, religion etc. 3. Patient fit for Virechana Karma. 4. Patient showing uric acid level above 7mg/dl. |
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years and above 60 years were excluded. 2. Patient with metabolic disorder, hypertension, systemic disorders, autoimmune diseases, any
endocrine disorder and any other malignancy. 3. Patient with infection and communicable disease.
4. Patients who are pregnant and lactating mother. 5. Patient associated with Rheumatoid arthritis, osteoarthritis. 6. Patient with anorectal diseases like fistula and hemorrhoids. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Arti (Pain)
2. Stabhdhata (Stiffness)
3. Svathu (Swelling)
4. Daha (Burning)
5. Vaivarnya (Discoloration) |
10,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective parameter
1. CBC with ESR
2. Serum uric acid |
10, 30 days |
|
|
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 |
|
Date of First Enrollment (India)
|
11/10/2024 |
| 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
|
This study is a Comparative Clinical evaluation of Virechana Karma with Kashmaryadi Kasahaya and Eranda Taila in Vatarakata (Gouty Arthritis)
This will be conducted on 40 randomly selected patients from Opd/Ipd of Panchakarma department of Patanjali Bhartiya Ayurvigyan evum Anusandhan Sansthan Haridwar. patient will be divided into 2 groups - 20 patients will be administered Kashmaryadi Kashaya for Virechana and 20 patients will be administered with Eranda Taila for Virechana. Follow up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. |