| CTRI Number |
CTRI/2024/02/062773 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Salt Glow Massage on Nerve
passage in patients with diabetic neuropathy - A
randomized controlled trial |
|
Scientific Title of Study
|
To determine the effect of Salt Glow Massage on Nerve
conduction in patients with diabetic peripheral neuropathy - A
randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kathiresan |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of naturopathy, second floor, Government yoga and naturopathy medical college and hospital, Arumbakkam, chennai, 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9715117211 |
| Fax |
|
| Email |
kathirbnys@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant medical officer cum Lecturer grade II |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of research, second floor, Government yoga and naturopathy medical college and hospital, Arumbakkam, chennai, 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kathiresan |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of naturopathy, second floor, Government yoga and naturopathy medical college and hospital, Arumbakkam, chennai, 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9715117211 |
| Fax |
|
| Email |
kathirbnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government yoga and naturopathy medical college and hospital, Arumbakkam,Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government yoga and naturopathy medical college and hospital, Arumbakkam,Chennai 600106 |
| 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 N Kathiresan |
Government Yoga and Naturopathy medical college and hospital |
Department of naturopathy, second floor, Government yoga and naturopathy medical college and hospital, Arumbakkam, chennai, 600106
Chennai
TAMIL NADU |
9715117211
kathirbnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy medical college and hospital, Chennai Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
neutral water immersion |
The control group will receive neutral water application (92 - 95áµ’ F) for 15 minutes on
alternate days for 2 weeks (a total of 7 sessions). |
| Intervention |
Salt Glow Massage |
The study group will be given 15 minutes of salt glow massage (SGM) as an intervention on
alternate days for two weeks (a total of 7 sessions). The participants will be instructed to wash the legs and will be
made lie-down in supine position on massage table. Epsom salt is applied with moist hands
over the wet surface of the legs and the Swedish massage will be given which includes the
following movements (stroking, circular friction, longitudinal friction, kneading). The
patient is free to withdraw at any time during the intervention in case of any discomfort. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Known case of diabetic neuropathy clinically diagnosed either by physician
or DN4 questionnaire.
A history of more than 3 months sensory symptoms of diabetic neuropathy.
Participant willing to give consent for the study |
|
| ExclusionCriteria |
| Details |
Participants with other sensory neurological complications
General contraindications (diabetic foot, open cuts and wounds, varicosity,
hypersensitive skin)
Participants with other systemic diseases
Pregnant women
Psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nerve conduction study |
Assessments will be taken before and after the
intervention period of 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual analog Scores
DN4 questionnaire |
Assessments will be taken before and after the
intervention period of 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/04/2024 |
| 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="5"
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
|
A randomized control study design will be adopted for this study. 20 participants will be recruited from Government Yoga and Naturopathy medical college and hospital and randomized into two groups of 10 namely study and control groups respectively. After baseline assessment of outcome variables, both the groups will undergo their respective interventions for a period of 2 weeks, after which post-assessments will be made. The study group will receive salt glow massage. The control group will receive neutral water application. Both groups will receive intervention for 15 minutes on alternate days for 2 weeks. The primary outcome variable will be Nerve conduction study. The secondary outcome variables will be visual analog scale, DN4 questionnaire. The values collected at baseline and after 2 weeks of intervention will be analyzed. |