| CTRI Number |
CTRI/2025/11/097546 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Patoladi kwath in treatment of vatarakta |
|
Scientific Title of Study
|
Role of patoladi kwatha in vatarakta(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 |
Jaspreet Kaur |
| Designation |
PG Scholar(Kaya Chikitsa) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar |
| Address |
OPD NO.1
Deptt. of
Kayachikitsa,
Rishikul
Campus,
U
tt
a
r
a
k
hand
Ay
u
r
v
e
d
University,
Haridwar
Uttrakhand
249401 India
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077747884 |
| Fax |
|
| Email |
Jasarora690@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrOm prakash Singh |
| Designation |
Professor |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar |
| Address |
OPD NO.1
Deptt. of
Kayachikitsa,
Rishikul
Campus,
U
tt
a
r
a
k
hand
Ay
u
r
v
e
d
University,
Haridwar
Uttrakhand
249401 India
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9411503035 |
| Fax |
|
| Email |
dr.opsingh64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaspreet kaur |
| Designation |
PG Scholar(Kaya Chikitsa) |
| Affiliation |
Rishikul Campus Haridwar Uttarakhand Ayurved University (Dehradun) Haridwar |
| Address |
OPD NO.1
Deptt. of
Kayachikitsa,
Rishikul
Campus,
U
tt
a
r
a
k
hand
Ay
u
r
v
e
d
University,
Haridwar
Uttrakhand
249401 India
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8077747884 |
| Fax |
|
| Email |
Jasarora690@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Rishikul Campus, Uttarakhand Ayurveda university, Haridwar, 249401, India |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University Dehradun |
| Address |
Uttarakhand Ayurved University, Station Road, Harrawala, Dehradun-248001 |
| 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 Jaspreet Kaur |
Rishikul campus, Uttarakhand Ayurved University Haridwar |
O.P.D NO.1 Deptt of kayachikitsa,Rishikul campus,Uttarakhand Ayurved
University,Haridwar Uttarakhand 249401 India
Hardwar
UTTARANCHAL |
8077747884
Jasarora690@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rishikul Campus Haridwar Uttarakhand Ayurved University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M205||Other deformities of toe(s) (acquired). Ayurveda Condition: VATARAKTAM, (2) ICD-10 Condition:M104||Other secondary gout. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi kwatha , Reference: Charakdutta 3/11, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with 3 or more of the classical symptoms
Patient willing to participate in the trial and with informed consent
Patients presenting with classical symptoms of Vatarakta :
Sandhi shotha ( Swelling )
Sandhi Ruka (Pain)
Sparshasahishnuta ( Tenderness )
Daha ( Burning sensation )
Twak vaivarnyata ( Discoloration)
Stabdhata( Stiffness )
Kandu ( Itching ) |
|
| ExclusionCriteria |
| Details |
Patients below 20 years or above 60 years.
Complicated cases of Vatarakta such as K/C/O chronic systemic disorders like RA, OA,
SLE, uncontrolled diabetes mellitus, HTN, tuberculosis, renal disease, malignancy,
hepatic diseases.
Patient with joint deformity, marked dysfunction, discharging tophi etc.
Pregnant and lactating mother.
Patients not willing to take the treatment or therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters
1.Sandhi sotha(Swelling)
2.Sandhi Ruka(Pain)
3.Sparshasahisnutha
4.Daha(Burning Sensation)
5.Twak Vaivarnyata
6.Stabdhata(Stiffness)
7.Kandu(Itching)
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in objective parameter
Serum uric acid |
4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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 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
|
Gout is a clinical syndrome and is a type of metabolic disease in which clinical manifestations are associated with tissue deposition of crystals of Monosodium Urate Monohydrate (MSUM) from hypouricemic body fluids.PatoladiKwath,which contains Patola, Katuki, Guduchi ,Shatavari, Haritaki, Vibhitaki ,Amalaki is a Classical Yoga which is Described in Charakdutta in VataraktaChikitsa. |