| CTRI Number |
CTRI/2024/02/062609 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the effect of Yoga and Naturopathy treatments in stroke patients |
|
Scientific Title of Study
|
The impact of Yoga and Naturopathy rehabilitation in post cerebrovascular accident patients - a single group pre post design
|
| 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 M Astalakshmi |
| Designation |
PG scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Dept of naturopathy, Second floor, Government Yoga and Naturopathy Medical College and Hospital PG block,
Arumbakkam,
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
6380703972 |
| Fax |
|
| Email |
astalakshmimanohar3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer, Department of Research |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Dept of Research, Second floor, Government Yoga and Naturopathy Medical College and Hospital PG block,
Arumbakkam,
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Astalakshmi |
| Designation |
PG scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Dept of naturopathy, Second floor, Government Yoga and Naturopathy Medical College and Hospital PG block,
Arumbakkam,
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
6380703972 |
| Fax |
|
| Email |
astalakshmimanohar3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical college and Hospital,Arumbakkam,chennai-106 |
|
|
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 M Astalakshmi |
Government Yoga and Naturopathy Medical college and Hospital |
2nd floor, Department of Naturopathy, Post Graduate block, Arumbakkam, Chennai-600106
Chennai
TAMIL NADU |
6380703972
astalakshmimanohar3@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: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Yoga and Naturopathy intervention |
The total duration of interventions will be 21 days. Enema will be given once on the first day of intervention. Nadishodhana pranayama, massage and passive exercises to the affected limbs, and a mud pack to the abdomen and eyes will be given daily. Steam bath will be given once a week. Auriculotherapy will be given five times per week. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants with 3 months after stroke
2)Participants able to stand with or without assistance
3)Participants able to walk with or without assistance
4)Age between 30 to 70 years
5)Male and female patients |
|
| ExclusionCriteria |
| Details |
1) Participants with uncontrolled hypertension
2) Participants with psychiatric illness
3) Participants with any type of cancer
4) Participants who are not willing to participate in the study
5) Participants who are with nasogastric tube or catheter
6) Participants with seizure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stroke specific Quality of life (SS-QOL) and Modified Barthel scale |
Stroke specific Quality of life (SS-QOL) and Modified Barthel scale will be measured before and after 21 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fugl-Meyer assessment scale,10-meter walk test and Handgrip strength |
Fugl-Meyer assessment scale,10-meter walk test and Handgrip strength will be measured before and after 21 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 single pre post design will be adopted for this study. 30 patients will be recruited from the Government Yoga and Naturopathy Medical College and Hospital as a single group. Baseline assessments will be taken before day 1 of the intervention. Integrated Yoga and Naturopathy intervention, which includes Nadishodhana pranayama, massage and passive exercises to the affected limbs, steam bath, mud pack to abdomen and eyes, auriculotherapy, and diet therapy, will be given for 21 days. The primary outcome measured will be stroke specific quality of life (SS-QOL) and Modified Barthel scale. The secondary outcomes measured will be Fugl-Meyer assessment scale, 10-meter walk test and Handgrip strength. Post assessments will be taken on the 21st day of intervention. |