| CTRI Number |
CTRI/2024/08/072178 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know the effect of vamana in the management of Kaphapradhana Vatarakta(Gouty Arthritis) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate the Efficacy of Mrduvamana in Kaphapradhana 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 |
Anivilla L P Vijaya Swapnika |
| Designation |
Post Graduate Scholar, Department of Panchakarma |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 20, Second Floor, Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9989413380 |
| Fax |
|
| Email |
swapnikaalpv18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen B S |
| Designation |
Vice Principal and Professor, Department of Panchakarma |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 20, Second Floor, Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9964006795 |
| Fax |
|
| Email |
praveenbs29@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen B S |
| Designation |
Vice Principal and Professor, Department of Panchakarma |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 20, Second Floor, Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India.
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9964006795 |
| Fax |
|
| Email |
praveenbs29@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai, 600123. |
|
|
Primary Sponsor
|
| Name |
Dr. Anivilla L P Vijaya Swapnika |
| Address |
Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Chennai, 600123. |
| 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 |
| Dr Anivilla L P Vijaya Swapnika |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room no 20, second floor, Department of Panchakarma, Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai, Thiruvallur, TAMIL NADU, India. 600123
Thiruvallur
TAMIL NADU |
9989413380
swapnikaalpv18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital, Department of Ayurveda, SCSVMV, Nazarathpet, Chennai. 600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | MRDUVAMANA | (Procedure Reference: Charaka Chikitsa 29th Chapter, Procedure details: Patient will be made to vomit by administering Vamaka dravya until attainment of 4 Vegas.)
(1) Medicine Name: Amrita Guggulu, Reference: Bhavaprakasha Madhyama Khanda, Route: Oral, Dosage Form: Guggulu, Dose: 500(mg), Frequency: bd, Duration: 60 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amrita Guggulu, Reference: Bhavaprakasha Madhyama Khanda, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: - Sukhoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient fit for Vamana karma.
Patients having signs and symptoms of Kaphapradhana Vatarakta (Gouty Arthritis). |
|
| ExclusionCriteria |
| Details |
Patients already diagnosed with Rheumatoid arthritis, Osteoarthritis, Osteoarthritis overlapping Gouty arthritis.
Patients who are pregnant/ lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the signs and symptoms of Kaphapradhana Vatarakta (Gouty ArthritiS) assessed by using CDAI and improve Range of Movements of affected joint assessed by using Goniometer. |
Patients from both the groups will be assessed after 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce serum uric acid levels |
Patients from both the groups will be assessed on day 0 and day 60 |
|
|
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 3 |
|
Date of First Enrollment (India)
|
26/08/2024 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Google Scholar
- For how long will this data be available start date provided 20-08-2024 and end date provided 30-08-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Vatarakta is a disease characterized by Toda, Daha, Kandu, Sopha, Sthambha, Antarbrisha Arthi, Sphurana and Sparsha Asahishnutwa. Vatarakata is classified into Vata, Pitta, Kapha and Rakta Pradhana varieties other than Utthana and Gambhira varieties. The Kapha Pradhana variety is characterized by Staimityam, Guruta, Supti, Snigdhatvam and Sheetata apart from Samanya Lakshana of Vatarakta. Gouty arthritis is a monoarticular arthropathy due to the
deposition of uric acid crystals within and around the joints. Gouty Arthritis is characterized by acute monoarthritic of rapid onset, severe pain, extreme tenderness, and marked swelling. The characteristic of the Gouty arthritis may be corelated to Kapha Pradhana Vatarakta in certain stages. Vamana Karma is a prime modality of treatment in treating diseases of Kapha. This is also beneficial in treating diseases where, Kapha is associated with Pitta and Kapha Sthanagata diseases. Vamana Karma is also performed in healthy persons as seasonal regimen. Mrduvamana is one of the treatment modalities explained in the management of Kaphapradhana Vatarakta. It might remove the rasagata Ama and thus may help in the recovery of the disease. Thus an attempt is made to evaluate the efficacy of Mrduvamana in Kaphapradhana Vatrakta (Gouty Arthritis). |