| CTRI Number |
CTRI/2021/11/038278 [Registered on: 26/11/2021] Trial Registered Prospectively |
| Last Modified On: |
01/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study held to see the effect of Godhum Yavadi Upnaha Sweda in Comparasion with Interferential Therapy with Exercise Therapy in treating Chronic Low Back pain. |
|
Scientific Title of Study
|
Randomized Comparative Clinical Study to Evaluate the Efficacy of Godhum Yavadi Upnaha Sweda and Interferential Therapy with Exercise Therapy in the Management of Chronic Low Back Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manmeet Kaur |
| Designation |
MD Scholar(Panchakarma) |
| Affiliation |
Dr. D.Y Patil College of Ayurved and Research Centre |
| Address |
Department of Panchakarma OPD no:9 Dr.D.Y.Patil College of Ayurved and Research Centre Sant Tukaram Nagar,pimpri,Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7889174529 |
| Fax |
|
| Email |
tanyamakkar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranesh Prakash Gaikwad |
| Designation |
MD Panchakarma |
| Affiliation |
Dr. D.Y Patil College of Ayurved and Research Centre |
| Address |
Department of Panchakarma OPD no:9 Dr.D.Y.Patil College of Ayurved and Research Centre Sant Tukaram Nagar,pimpri,Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8668259365 |
| Fax |
|
| Email |
pranesh.gaikwad@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manmeet Kaur |
| Designation |
MD Scholar(Panchakarma) |
| Affiliation |
Dr. D.Y Patil College of Ayurved and Research Centre |
| Address |
Department of Panchakarma OPD no:9 Dr.D.Y.Patil College of Ayurved and Research Centre Sant Tukaram Nagar,pimpri,Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7889174529 |
| Fax |
|
| Email |
tanyamakkar24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurved and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Manmeet kaur |
| Address |
Department of Panchakarma OPD no:9 Dr.D.Y.Patil College of Ayurved and Research Centre Sant Tukaram Nagar,pimpri,Pune 411018 |
| Type of Sponsor |
Other [self] |
|
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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 Manmeet kaur |
Dr D Y Patil College of Ayurved and Research Centre |
OPD no:9 Panchkarma dept Dr.D.Y.Patil College of Ayurved and Research Centre Sant Tukaram Nagar,pimpri,Pune 411018
Pune
MAHARASHTRA |
7889174529
tanyamakkar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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:M472||Other spondylosis with radiculopathy. Ayurveda Condition: Katishoola, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Interferntial therapy | •In GODHUMYAVADI UPNAHA SWEDEN paste of vaat mitigating drugs mixed with sour liquid,salts and fats applied over affected part approx. 6 hours. Due to its longer duration it has effect on deep smooth muscles and nerves.
INTERFERENTIAL THERAPY is an electrotherapeutic modality An form of electrical treatment in which two medium frequency currents are used to produce low frequency current at the point of intersection.It helps to reduce pain and muscle spasm. |
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.patients having non specific chronic low back pain that is patient having pain for 3 months or more than that will be taken as a subject to study.
|
|
| ExclusionCriteria |
| Details |
1.Congenital structural deformities.
2.Low back pain results from spinal fractures,infections,neoplasms.
3.Known case of skin allergy and open wound.
4.Patient who will not give written consent. |
|
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effect of Godhum Yavadi Upnaha Sweda and Interferential Therapy with Exercise Therapy in Reduction of Chronic Low Back Pain. |
14 days study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Reduction in stiffness and increase in flexibility |
14 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is the clinical study to evaluate the comparative efficacy of Godhum yavadi Upnaha Sweda and Interferential Therapy with exercise therapy in the Management of Chronic Low Back pain.Study Design is Randomized Comparative Clinical trial study Total 70 patients will be enrolled Group A(35 patients)-will be given Godhum Yavadi Upnaha Sweda+Exercise therapy for 7 days Group B(35 Patients)-will be given interferential therapy +Exercise therapy for 7 days Two follow ups will be there on 7th and 14th day Total duration of study will be 18 months |