CTRI Number |
CTRI/2018/04/013048 [Registered on: 04/04/2018] Trial Registered Retrospectively |
Last Modified On: |
04/04/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective study |
Study Design |
Other |
Public Title of Study
|
A study to find out the differences in the treatments of low back pain with radiating pain to leg among 3 doctors in Amrita school of Ayurveda |
Scientific Title of Study
|
An observational prospective study to find out the converging and diverging factors in the treatment protocol of sciatica among the physicians of Panchakarma department at Amrita school of Ayurveda |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ajisha DH |
Designation |
PG Scholor |
Affiliation |
Amrita school of Ayurveda |
Address |
PG Scholor
Department of Panchakarma
Amrita school of Ayurveda
Clappana PO
Vallikavu, Kollam Raj bhavan
Venkavila
Vattavila PO
695132 Thiruvananthapuram KERALA 690525 India |
Phone |
9495521660 |
Fax |
|
Email |
drajisha13jan@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Anandaraman P V |
Designation |
Associate professor |
Affiliation |
Amrita school of Ayurveda |
Address |
Associate professor
Department of Panchakarma
Amrita school of Ayurveda
Clappana PO
Vallikavu, Kollam
Kollam KERALA 690525 India |
Phone |
9495130595 |
Fax |
|
Email |
dr.ananthramsharma@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Anandaraman P V |
Designation |
Associate professor |
Affiliation |
Amrita school of Ayurveda |
Address |
Associate professor
Department of Panchakarma
Amrita school of Ayurveda
Clappana PO
Vallikavu, Kollam
KERALA 690525 India |
Phone |
9495130595 |
Fax |
|
Email |
dr.ananthramsharma@gmail.com |
|
Source of Monetary or Material Support
|
Amrita School of Ayurveda
clappana p o
vallikavu, kollam |
|
Primary Sponsor
|
Name |
Dr Ajisha DH |
Address |
PG Scholor
Amrita school of Ayurveda
Clappana PO
Vallikavu, Kollam 690525 |
Type of Sponsor |
Other [] |
|
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 |
Ajisha D H |
Amrita school of ayurveda |
Amrita school of ayurveda, clappana p o , vallikavu, kollam Kollam KERALA |
9495521660
drajisha13jan@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Amrita institute of medical sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
sciatica , |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
• Patients who are diagnosed by the physicians as Gridhrasi and assessed by a Physiotherapist being ≥70% confident of a diagnosis of sciatica.
• Patients with signs and symptoms of Sciatica mentioned in ICD 10
|
|
ExclusionCriteria |
Details |
1)Patients who are diagnosed by Physician as Gridhrasi and the Physiotherapist is not confident enough to diagnose as Sciatica
2)Known case of neoplasm, bone TB, fracture of spine, malignancy, uncontrolled diabetes and uncontrolled hypertension
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
convergence and divergence in the treatment protocol of sciatica |
After each set of treatments and follow up |
|
Secondary Outcome
|
Outcome |
TimePoints |
divergence in the treatment protocol of sciatica |
6 months |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 1 |
Date of First Enrollment (India)
|
09/03/2018 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
09/03/2018 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="10" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Sciatica is a condition where there is distribution of pain along the course of sciatic
nerve, i.e, which the pain radiates from the low back to buttock and legs.
Sciatica of contemporary medical science is closely equivalent to Gridhrasi by
its similarity in the course of pain.
On considering sciatica
as an independent disease it is a relatively common condition with lifetime
incidences varying from 1.6%-43%. The chance of Sciatica is expected to
increase in the upcoming years due to sedentary life style, the increased use
of computerization and also due to increasing body weight, mental stress, hectic
work schedules and transportation methods.
Ayurveda treatment claims high success rate in
Sciatica. Even though the symptoms exhibited by the patients are same,
treatment protocol changes from physicians to physician may be based on logic
in assessing dosha and dushya.
So the aim of the study is to find out the converging and diverging
factors in the treatment protocol of Sciatica among the physicians.
20
patients each of 3 physicians in Panchakarma IPD of Amrita school of ayurveda,
suffering from sciatica will be selected
and the treatment and condition will be observed. Later convergence and
divergence will be recorded. After analyzing all these the overall convergence
and divergence can be listed out with the logic behind it. |