| CTRI Number |
CTRI/2019/12/022427 [Registered on: 18/12/2019] Trial Registered Prospectively |
| Last Modified On: |
17/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Valuka sweda with and without Interferential Therapy (IFT) in Katigraha] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Valuka sweda (Hot Sand bag Sudation) with and without Physiotherapy (IFT) in Lowback pain |
|
Scientific Title of Study
|
“A COMPARATIVE CLINICAL STUDY OF VALUKA SWEDA WITH AND WITHOUT INTERFERENTIAL THERAPY (IFT) IN KATIGRAHA.â€
|
| Trial Acronym |
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|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUMIT PATIL |
| Designation |
Ph.D. Scholor |
| Affiliation |
Bharati Vidyapeeth Deemed university, Pune College of Ayurved Dhankawdi, Pune 411043 |
| Address |
Post Graduate Department of Panchakarma, Bharati vidyapeeth Deemed to be university College of Ayurved and Hospital, Dhankawdi, Pune, 411043, OPD Room No. 24
Kolhapur
MAHARASHTRA
416005
India |
| Phone |
08788331197 |
| Fax |
|
| Email |
dr.sumit.ayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra M Vedpathak |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth Deemed university, Pune College of Ayurved Dhankawdi, Pune 411043 |
| Address |
Department of Panchakarma, Bharati Vidyapeeth Deemed to be University College of Ayurved, Dhankawdi, Pune, 411043. Maharashtra, India
Pune
MAHARASHTRA
411043
India |
| Phone |
7030309088 |
| Fax |
|
| Email |
drsurendravedpathak50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surendra M Vedpathak |
| Designation |
Professor and HOD |
| Affiliation |
Bharati Vidyapeeth Deemed university, Pune College of Ayurved Dhankawdi, Pune 411043 |
| Address |
Department of Panchakarma, Bharati Vidyapeeth Deemed to be University College of Ayurved, Dhankawdi, Pune, 411043. Maharashtra, India
Pune
MAHARASHTRA
411043
India |
| Phone |
7030309088 |
| Fax |
|
| Email |
drsurendravedpathak50@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Panchakarma Bharati Vidyapeeth deemed to be university college of Ayurved Dhankawadi Pune 411043 |
|
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Primary Sponsor
|
| Name |
Bharati Vidyapeeth Medical Foundation Ayurveda Hospital Pune |
| Address |
Bharati Vidyapeeth deemed to be university college of Ayurved Dhankawadi Pune Department of Panchakarma, OPD N0.24 Ground Floor. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumit Raosaheb Patil |
Bharati Vidyapeeth Foundation Ayurved Hospital |
Bharati Vidyapeeth Deemed to be University college of
Ayurved Dhankawadi Pune Maharashtra, Department of
Panchakarma.
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
08788331197
dr.sumit.ayu@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth Deemed to be University College of Ayurved |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
VALUKA SWEDA |
Group B- Valuka sweda; for 14 days of Duration,follow up 30th day |
| Intervention |
VALUKA SWEDA WITH INTERFERENTIAL THERAPY (IFT) |
Group A- Valuka Sweda with Interferential Therapy (IFT) for 14 days of Duration both the therapies, morning time Valuka sweda and Interfetential Therapy after hour later, follow up 30th day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a.Patients with symptoms of Katishula and Katigraha
b.Patients willing to give consent
c.Patients aged between 20 to 60 years.
d.Patients with gender from either category.
e.Patient fit for Valuka Sweda and IFT.
|
|
| ExclusionCriteria |
| Details |
1) For Valuka Sweda & IFT
a.Non-mechanical causes of back pain (e.g., sciatica, systemic/visceral disease, pregnancy, spondylolisthesis, spinal stenosis, cancer, recent vertebral fracture).
b.Traumatic and congenital deformities condition of the spine.
c.Any surgical condition.
d.Skin diseases.
2) Specifically For Interferential Therapy(IFT)
a)Patients taking anticoagulation therapy, having history of Pulmonary embolism, Deep vein thrombosis
b)Active and suspected malignancy
c)Patient with Pacemakers
d)Dermatological conditions e.g. Dermatitis any other skin diseases
e)Hemorrhagic disorders.
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|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Valuka sweda with Interferential Therapy (IFT) will have better results in Management of Katigraha compared to Valuka Sweda alone. |
Day-1
Day-15
Day-30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •There is no difference between efficacy of Valuka Sweda with and without Interferential Therapy in Management of Katigraha. |
Day-1
Day-15
Day-30 |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/12/2019 |
| 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 |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Katigraha is the disease characterized by vitiation of Vata dosha in the self site and got avarana with the help of Kapha dosha, leading to development of symptoms like Katishula and Katigraha. · Many people suffering from Katigraha were working or doing household jobs. So for them it’s very difficult to perform there day to day activities having pain and stiffness at Lowback region. · Valuka sweda in Katigraha is proven modality hence in this study we are comparing the Valuka sweda with and without IFT as add on effect of therapy which has not yet been done. Number of Patients- Total 100 Two Groups- Group A- Valuka sweda with Interferential Therapy- 50 Patients Group B- Valuka sweda- 50 Patients Duration of Treatment of Each Procedure- 14 days Total Duration - 30 days including follow up. Assessment- Day-1 (Before Treatment), Day-15 (After Treatment), Day- 30 (Follow up -last)
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