| CTRI Number |
CTRI/2024/11/077485 [Registered on: 29/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the effect of yoga practice along with conventional treatment in clinical and psychosocial parameters among adults in the age group of 20-60 years with Auto immune Myasthenia Gravis |
|
Scientific Title of Study
|
The effectiveness of modified yoga techniques in improving clinical and psychosocial parameters among adults with Autoimmune Myasthenia Gravis A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PHD221712A |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renjumol VS |
| Designation |
Part time PhD scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Assistant Professor
Department of Swasthavritta
Government Ayurveda College Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
8547787042 |
| Fax |
|
| Email |
dr.renjumol@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Giri PV |
| Designation |
Professor and Guide |
| Affiliation |
vaidyaratnam ayurveda college Trissur |
| Address |
Department of Kayachikitsa, Vaidyaratnam Ayurveda College , Trissur
Thrissur
KERALA
680306
India |
| Phone |
9605659777 |
| Fax |
|
| Email |
doctorviswagiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renjumol VS |
| Designation |
Part time PhD Scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Assistant Professor Department of Swasthavritta Government Ayurveda College Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
8547787042 |
| Fax |
|
| Email |
dr.renjumol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neurology Sree Chitra Tirunal Institute for Medical Sciences and Technology Thiruvananthapuram Kerala India 695011 |
| Department of Swasthavritta Government Ayurveda College Tripunithura Ernakulam Kerala India 682301 |
|
|
Primary Sponsor
|
| Name |
Renjumol VS |
| Address |
Part time PhD Scholar Assistant Professor Department of Swasthavritta Government Ayurveda College Tripunithura Ernakulam India 682301 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sruthi S Nair |
Additional Professor Department of Neurology SCTIMST Thiruvananthapuram |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RENJUMOL VS |
Government Ayurveda College Tripunithura |
Department Of Swasthavritta ,Government Ayurveda College Tripunithura, Ernakulam, Kerala 682301
Ernakulam
KERALA |
8547787042
dr.renjumol@gmail.com |
| Dr Sruthi S Nair |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Department of Neurology, SCTIMST, Thiruvananthapuram
Thiruvananthapuram
KERALA |
04712524488
sruthisn@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Government Ayurveda College Tripunithura |
Approved |
| IEC SCTIMST Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G700||Myasthenia gravis. Ayurveda Condition: DHATVAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: NA, Ritucarya: NA, Acara Rasayana:NA, Other:Regular online practice of modified yoga techniques under the guidance of principal investigator for 3 months, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | Control Group | Intervention period is 3 months. Both groups will be suggested to follow conventional treatment such as steroid use, physiotherapy etc. In addition to that the study group will be received online yoga practices. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with class II MG, II a MG, II b MG, III MG, III a MG, III b MG, IV MG, IV a MG, clinical classification of the Myasthenia Gravis Foundation of America (MGFA)
2. Patient with mild and moderate QMG score
3. MG-ADL more than 2score
4. Myasthenia Gravis patient complaints with Fatigue
5. Subject within the age group 20 to 60 years in both sex
6. Patients willing for regular follow up and evaluation during the period of study
7. Dose of immunotherapy stable in last 2 months prior to recruitment |
|
| ExclusionCriteria |
| Details |
1. Pregnant woman and lactating mother
2. Patients having malignancy, severe systemic illness, COPD
3. Patient unable to perform yoga postures from minimum required yoga procedure
4. Patients who are not giving consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The Quality of Life of patients with Autoimmune Myasthenia Gravis measured by Myasthenia Gravis Quality of Life 15 (MG-QoL15) scale
2. Fatigue of patients with Autoimmune Myasthenia Gravis measured by Fatigue Severity Scale (FSS) |
Study Duration 4 years. Assessment will be done on 0th and 91st day of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The anxiety and depression of patients with Autoimmune Myasthenia Gravis measured by HADS scale and stress by Perceived stress scale |
Assessment will be done on 0th day, 45th day and 91st day of the study.
|
| Sleep apnea in patients with Autoimmune Myasthenia Gravis measured by STOP-BANG Sleep Apnea Questionnaire |
0th and 91st day of the study |
| Activities of Daily Living (MG-ADL), MG QMG score, Myasthenia Gravis Composite (MGC) |
0th and 91st of the study |
| Relapse rate, Frequency of infection and Reducing steroid doses in these subjects by standard questionnaire in patients with Autoimmune Myasthenia Gravis |
0th 45th and 91st day of the study |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/12/2024 |
| 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="2"
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
|
This is a Collaborative study ( RCT) will be done on the part of PhD study of Department of Swasthavritta, Government Ayurveda College Tripunithura ( study centre) with Department of Neurology Sree Chitra Tirunal Institute of Medical Sciences and Technology Thiruuananthapram ( Collaborating centre). 70 participants with Auto immune Myasthenia Gravis, satisfying inclusion and exclusion criteria will be selected from SCTIMST by consecutive sampling and online Yoga sessions will be done at Government Ayurveda College Tripunithura. The 70 participants will be allocated to Study and Control group, 35 in each group, by SNOSE randomization. Concealed allocation and randomization will be done on the day of recruitment by the PhD scholar . All the subjects will have a unique code the key to which will be kept with PhD scholar. Both groups will be suggested to follow their conventional treatment and in addition to that the study group will be received 3month online yoga practices . There will be two sessions , morning and evening. only 3-5 participants will be selected for one session. Total study duration is 4 years .
The primary outcomes are QOL15r and FSS scale will be assessed on 0th and 91st day directly at SCTIMST and on 45th day by online questionnaire filled by patient. The secondary outcomes are HADS ,Perceived Stress Scale, ( assessment 0th 45th and 91st day ) and QMG, MGC, MG-ADL, STOP BANG and other Structured questionnaires will be assessed on 0th and 45th day of the study.
|