| CTRI Number |
CTRI/2021/09/036419 [Registered on: 10/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MANAGEMENT OF GOUT WITH AYURVEDIC MEDICINE RECTAL ADMINISTRATION PROCEDURE |
|
Scientific Title of Study
|
CLINICAL STUDY ON YASTAYAHVA NIRUH BASTI IN THE MANAGEMENT OF VATARAKTA
(GOUT) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naina Vishnoi |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU JODHPUR |
| Address |
PG Department of Panchakarma University college of ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9694217513 |
| Fax |
|
| Email |
nainabhadu1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar Sharma |
| Designation |
HOD And Professor |
| Affiliation |
DSRRAU JODHPUR |
| Address |
PG Department of Panchakarma University college of ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829695452 |
| Fax |
|
| Email |
drmksharma2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar Sharma |
| Designation |
HOD And Professor |
| Affiliation |
DSRRAU JODHPUR |
| Address |
PG Department of Panchakarma University college of ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829695452 |
| Fax |
|
| Email |
drmksharma2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur PIN:342037 |
| 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 Mahesh Kumar Sharma |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,University hospital of Ayurveda |
OPD No-6,P.G.DEPARTMENT OF PANCHAKARMA,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University,Karwar,Nagaur Road ,Jodhpur PIN:342307
Jodhpur
RAJASTHAN |
9829695452
drmksharma2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | YASTAYAHVA NIRUH BASTI | (Procedure Reference: CHARAKA SAMHITA, Procedure details: YASTAYAHVA NIRUH BASTI 480 ml FOR 6 DAYS AND MADHUYASTI SIDHA TAILA ANUVASAN BASTI 120 ml FOR 10 DAYS Duration.(RECTAL ADMINISTRATION))
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having serum uric acid level above 5mg/dl and presenting the sign and symptoms of GOUT
2.Patients indicated for basti karma |
|
| ExclusionCriteria |
| Details |
1.Patient having other debiliatory disease.
2.Chronicity for more than 10 years
3.Having severe crippling deformity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameters |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the clinical efficacy of the treatment in single group |
30 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
13/09/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gout is a condition that can lead to pain when it flares up and inflammatory Arthritis. Gout is more distressing and common metabolic disorder prevalent in present days.The non-steroid anti-inflammatory drugs(NSAID’s) and corticosteroid which are usually prescribed for Gout in modern science can have a range of side effect.Therefore,its high time to provide the patients of gout with less complicating , fruitful management through ayurveda.This study is an open labelled single group trial to prove the efficacy of Yastayahva Niruh Basti in the management of Vatarakta w.s.r. Gout. |