| CTRI Number |
CTRI/2025/09/094260 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [basti ] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The Comparision between the Yashtywha kadha basti treatment and tab febuxostat tratment in Gout patients. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Yashtyawha kal basti and Tab.
Febuxostat (40 mg BD) in Vatrakta w.s.r Gout |
| 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 Anushri Vasant Netke |
| Designation |
assistant professor |
| Affiliation |
AYUSH |
| Address |
Maharashtra University of Health Sciences, Nashik
Maharashtra University of Health Sciences, Nashik
Nashik
MAHARASHTRA
422009
India |
| Phone |
07038611626 |
| Fax |
|
| Email |
anetke939@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anushri Vasant Netke |
| Designation |
assistant professor |
| Affiliation |
AYUSH |
| Address |
Maharashtra University of Health Sciences, Nashik
Maharashtra University of Health Sciences, Nashik
MAHARASHTRA
422009
India |
| Phone |
07038611626 |
| Fax |
|
| Email |
anetke939@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anushri Vasant Netke |
| Designation |
assistant professor |
| Affiliation |
AYUSH |
| Address |
Maharashtra University of Health Sciences, Nashik
Maharashtra University of Health Sciences, Nashik
MAHARASHTRA
422009
India |
| Phone |
07038611626 |
| Fax |
|
| Email |
anetke939@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anushri Vasant Netke
Maharashtra University of Health Sciences, Nashik |
|
|
Primary Sponsor
|
| Name |
Dr Anushri Vasant Netke |
| Address |
Maharashtra University of Health Sciences, Nashik |
| 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 Anushri Vasant Netke |
Room no. 23, Maharashtra Post graduate institute, Nashik |
Trambak naka
Nashik
MAHARASHTRA |
07038611626
anetke939@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri saptashrungi ayurved mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M100||Idiopathic gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Febuxostat | 40 mg BID for 16 days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: CARAK SIDDHISTHAN 3/46, Procedure details: The different components of Vasti will be mixed in following way. First 120 gm Madhu will be taken, then 5 gm Saindhava Lavana will be added and triturated thoroughly with a help of wooden churner, to this will be warmed, 120 ml Go-Ghritha will be slowly added and mixed well, then 80 gm Kalka made of Sataha, Pippali and Madanaphala will be added; now 640 ml Yashtimadhu Ksheerapaka which is freshly prepared will be added. All the ingredients will be thoroughly mixed and a preparation without sedimentation would be obtained, this will be made Sukhoshna by keeping it over Ushna Jala. The total amount of Vasti prepared will be 960 ml.)
(1) Medicine Name: Febuxostat, Reference: modern medicine, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 40(mg), Frequency: bd, Duration: 16 Days | | 3 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: carak siddhisthan3/46, Procedure details: Yashtyawha kal basti per day for 16 days
The different components of Vasti will be mixed in following way. First 120 gm Madhu will be taken, then 5 gm Saindhava Lavana will be added & triturated thoroughly with a help of wooden churner, to this will be warmed, 120 ml Go-Ghritha will be slowly added & mixed well, then 80 gm Kalka made of Sataha, Pippali & Madanaphala will be added; now 640 ml Yashtimadhu Ksheerapaka which is freshly prepared will be added. All the ingredients will be thoroughly mixed & a preparation without sedimentation would be obtained, this will be made Sukhoshna by keeping it over Ushna Jala. The total amount of Vasti prepared will be 960 ml. )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
2. Diagnosed Patients presenting with classical clinical features of Vatarakta.
3. Basti Yogya Patients
4. Increased sr. Uric acid levels more than 7mg/ dl in male and more than 6 mg/dl in female
|
|
| ExclusionCriteria |
| Details |
1. Pregnant Women and Lactating Mother
2. Hemorthrosis, Koch’s Arthritis, Septic Arthritis, Chronic Renal Failure, Severe Systemic Multi organ syndromes
3. Patient having any other systemic disorder viz. Diabetes Mellitus, Hypertension, abnormal liver enzymes etc. etc.
4. Basti Ayogya Patients
5. Patients with long standing use of corticosteroids
6. Gout with complications- joint damage, joint deformity, bone loss, tophi deposits etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Yashtywha kal basti and tab febuxostat 40 mg and combined effect of both treatment in Vatrakta w.s.r. Gout |
BASELINE,1ST, 16TH, 45TH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate the effect of Yashtyahwa Kal basti in the patients of vatrakta over a treatment period of 15 days.
• To evaluate the effect of Tab Febuxostat 40 mg BD in the patients of vatrakta over a treatment period of 15 days.
• To compare the clinical efficacy of Yashtyahwa Kal basti with Tab Febuxostat 40 mg BD in treatment of Vatrakta over a total duration of 45 days.
• To study the combined effect of Yashtyahwa Kal basti & Tab Febuxostat in Vatrakta over a total duration of 45 days.
• To observe the effect of the Yashtyahwa Kal basti, Tab Febuxostat & combination of both treatments on Sr. Uric acid levels, CRP & ESR on 0, 17th & 45th day.
|
baseline,1st, 16th, 30th, 45th |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/09/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anetke939@gmail.com].
- For how long will this data be available start date provided 28-08-2025 and end date provided 28-08-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
There’s no optimal cure for Gout in modern science as analgesics, uric acid reducer, nonsteroidal anti-infammatory drug and steroid thus an attempt has been made to bridge the gap in studying and standardizing the mentioned basti karma. Instead of the wide range of success of Panchakarma in Vatrakta treatment there are very few published data available or the data available is in the form of single arm study or non controlled clinical trial, so, to validate the data we need more clinical trials on Basti.
Aims and Objectives- Aims Clinical evaluation and comparison of clinical efficacy (including symptomatic relief Sr. Uric Acid levels and CRP levels) and overall improvement by Yashtyawha Kal Basti alone, Tab Febuxostat (40 mg BD) and Yashtyawha Kal Basti combined with Tab Febuxostat (40 mg BD) only in the treatment of Vatrakta w.s.r to Gout. Objectives To evaluate the effect of Yashtyahwa Kal basti in the patients of vatrakta over a treatment period of 15 days. To evaluate the effect of Tab Febuxostat 40 mg BD in the patients of vatrakta over a treatment period of 15 days. To compare the clinical efficacy of Yashtyahwa Kal basti with Tab Febuxostat 40 mg BD in treatment of Vatrakta over a total duration of 45 days. To study the combined effect of Yashtyahwa Kal basti and Tab Febuxostat in Vatrakta over a total duration of 45 days.Method Of Selection Of Study Subjective Diagnosis Criteria:- Diagnosis is done based on the sign and symptoms of Vataraktai.e. Sandhi Toda (Pricking Pain of Joints) Sandhi Daha (Burning Sensation of the Joints) Supthi (Numbness) Sparshaasahyatha (Tenderness) Raaga (Discolouration of Joints) Sandhi Shotha (Swelling)
Methodlogy Group A (Trial) - Yashtyahwa Niruha Basti (45 Sample) Group B (Control) – Tab. Febuxostat 40 mg x BD (45 Sample) Group A (Trial) - Yashtyahwa Niruha Basti and Tab. Febuxostat 40 mg x BD (45 Sample Data Analysis Plan and MethodsData Management and Analysis Procedure 1. Collected data will be summarized in the form of master charts. Further classification and presentations will be done in the form of tables and graphs. 3. Finally, data will be analyzed statistically to draw conclusions. Plan For Statistical AnalysisResult of study will be calculated statistically with appropriate statistical method for subjective and objective criteria. Data collected will be analyzed by statistical tests As well as another relevant test if required. Discussion Discussion will be done on the basis of observations and result obtained during the treatment of patients. Summary and Conclusion On the basis of observations, discussion and result; summary will be draw and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.
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