| CTRI Number |
CTRI/2021/02/031501 [Registered on: 23/02/2021] Trial Registered Prospectively |
| Last Modified On: |
19/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A comparative clinical trial of Valuka Pottali Sweda with Short Wave Diathermy (SWD) in Amavata. |
|
Scientific Title of Study
|
A comparative clinical trial of Valuka Pottali Sweda with Short Wave Diathermy (SWD) in Amavata. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RUPALI SURESHRAO GURJAR |
| Designation |
M. D. SCHOLAR PANCHAKARMA |
| Affiliation |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA, MALWADI, HADPASAR, PUNE 411028 |
| Address |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAYA,HADPSAR,PUNE,MAHARASHRTA, INDIA 411028
OPD NO. 6, DEPARTMENT OF PANCHAKARMA,SANE GURUJI AROGYA KENDRA,MALWADI,HADAPSAR,PUNE 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
7756958807 |
| Fax |
|
| Email |
rupaligurjar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAYA GOKHALE |
| Designation |
HOD OF PANCHAKARMA |
| Affiliation |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAY,MALWADI,HADAPSAR,PUNE |
| Address |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAY,HADAPSAR,PUNE,MAHARASHTRA,INDIA 411028
OPD NO. 6, DEPARTMENT OF PANCHAKARMA,SANE GURUJI AROGYA KENDRA,MALWADI,HADAPSAR,PUNE 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RUPALI SURESHRAO GURJAR |
| Designation |
M. D. SCHOLAR PANCHAKARMA |
| Affiliation |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAY,MALWADI,HADAPSAR,PUNE |
| Address |
SUMATIBHAI SHAH AYURVEDA MAHAVIDYALAY,HADAPSAR,PUNE,MAHARASHTRA,INDIA 411028
OPD NO. 6, DEPARTMENT OF PANCHAKARMA,SANE GURUJI AROGYA KENDRA,MALWADI,HADAPSAR,PUNE 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
7756958807 |
| Fax |
|
| Email |
rupaligurjar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PANCHAKARMA,SANE GURUJI AROGYA KENDRA,MALWADI,HADAPSAR,PUNE 411028 |
|
|
Primary Sponsor
|
| Name |
SANE GURUJI AROGYA KRNDRA |
| Address |
SANE GURUJI AROGYA KENDRA,MALWADI,HADPSAR,PUNE 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RUPALI SURESHRAO GURJAR |
SANE GURUJI AROGYA KENDRA |
OPD NO.6 DEPARTMENT OF PANCHAKARMA,SANE GURUJI AROGYA KENDRA,MALWADI,HADAPSAR,PUNE
Pune
MAHARASHTRA |
7756958807
rupaligurjar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M259||Joint disorder, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SHORT WAVE DIATHERMY THERAPY |
DOSE- SHORT WAVE DIATHERMY THERAPY FOR 20-25 MINUTES
FREQUENCY- DAILY FOR 7 DAYS
ROUTE OF ADMINISTRATION- EXTERNAL APPLICTION ON JOINTS
DURATION- 7 DAYS |
| Intervention |
VALUKA POTTALI SWEDA |
DOSE- SWEDAN FOR 20-25 MINUTES
FREQUENCY- DAILY FOR 7 DAYS
ROUTE OF ADMINISTRATION- EXTERNAL APPLICTION ON JOINTS
DURATION- 7 DAYS |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Swedan Arha SWD indicated |
|
| ExclusionCriteria |
| Details |
Patient of joint pain other than Amavata Systemic diseases Swedan Anrha All SWD contraindicated |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECT OF TWO MODALITIES VALUKA POTTALI SWEDA AND SHORT WAVE DIATHERMY (SWD) IN AMAVATA |
ASSESSMENT ON 7TH DAY AND 15TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE EFFECT OF SHORT WAVE DIATHERMY(SWD) IN AMAVATA WITHIN 7 DAYS |
PATIENT WILL BE ASSESSED ON 0,3,7,15TH DAY |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS A COMPARATIVE CLINICAL TRIAL OF VALUKA POTTALI SWEDA WITH SHORT WAVE DIATHERMY (SWD) IN AMAVATA . THE PRIMARY OBJECTIVE IS TO COMPARE THE EFFECT OF VALUKA POTTALI SWEDA AND SHORT WAVE DIATHERMY (SWD) IN SYMPTOMS OF AMAVATA. ONE GROUP OF AMAVATA PATIENTS WILL BE TREATED WITH VALUKA POTTALI SWEDA FOR 7 DAYS SECOND GROUP OF AMAVATA PATIENTS WILL BE TREATED WITH SHORT WAVE DIATHERMY (SWD) FOR 7 DAYS.OBSERVATION WILL BE DRAWN FROM THE OUTCOME OF TREATMENT. |