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CTRI Number  CTRI/2024/04/065293 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 03/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Physiotherapy with Yoga]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of alternative therapies on pain, anxiety, quality of sleep, ADLs and quality of life in patients with bilateral chronic leg pain. 
Scientific Title of Study   Effects of exercises and yoga asanas on pain, anxiety, quality of sleep, activities of daily living and quality of life in patients with pain in both the legs. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ms. Antara Bishnu 
Designation  Research Scholar 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of Physiotherapy, School of Allied Health sciences, Manav Rachna International Institute of Research and Studies, Faridabad-Haryana, 121004
Faridabad
HARYANA
121004
India 
Phone  7047600267  
Fax    
Email  bishnuantara@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Sethi 
Designation  Assistant Professor 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of Physiotherapy, School of Allied Health sciences, Manav Rachna International Institute of Research and Studies, Faridabad-Haryana, 121004
Faridabad
HARYANA
121004
India 
Phone  7042637002  
Fax    
Email  priyankasethi.sahs@mriu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr. Priyanka Sethi 
Designation  Assistant Professor 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Department of Physiotherapy, School of Allied Health sciences, Manav Rachna International Institute of Research and Studies, Faridabad-Haryana, 121004
Faridabad
HARYANA
121004
India 
Phone  7042637002  
Fax    
Email  priyankasethi.sahs@mriu.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  MS. ANTARA BISHNU 
Address  SONATORE PARA, R N T ROAD, PS- SURI, PO- SURI, DIST- BIRBHUM, WB, 731101. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
MS ANTARA BISHNU  Manav Rachna International Institute of Research and Studies  Manav Rachna Campus Rd, Gadakhor Basti Village, Sector 43, Faridabad, Haryana 121004
Faridabad
HARYANA 
7047600267

bishnuantara@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE AT THE SCHOOL OF ALLIED HEALTH SCIENCES, MRIIRS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G258||Other specified extrapyramidal andmovement disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparator Agent Group A -– Physiotherapy with affirmation training for six weeks.  Exercise protocol design for restless leg syndrome targeting gastrocnemius medialis and gastrocnemius lateralis muscle for both leg along with affirmation training.  
Intervention  Comparator Agent Group B - consisted Yoga with affirmation training for six weeks.  Utkatasana yoga asana along with affirmation. 
Comparator Agent  Group C- Physiotherapy with affirmation and Yoga with affirmation both applied on alternate days for six weeks  Group A and group B protocol would be given to the patient on alternate days.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Inclusion Criteria Inclusion Criteria
1. Age between of 20-45 years.
2. Newly diagnosed with IRLSSG SCALE (mild- moderate)
3. Having pain more than 3 months (VAS score; 3-8)
4. Both the genders.
- Untreated with any medication.
- Disturbed sleep
- Reflecting worse QoL (lower score of SF-36)
 
 
ExclusionCriteria 
Details  Exclusion Criteria
1. Diagnostic case of psychosomatic or psychotic disorder.
2. Any history of sensory loss.
3. Recent history of musculoskeletal or neurological impairments or any neuromuscular disease.
4. Any history of sensory loss.
5. No medical complain including BP, Diabetes, renal failure, cardiac pacemaker, pregnancy any other physiological problem.
6. Abnormal NCS findings.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome
1. Pain, anxiety and Sleep
 
Day-0
Day-42
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Activities of Daily Living
2. Quality of Life 
Day-0
Day-42 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   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="0"
Months="6"
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  

The study protocol was approved by the research ethical committee of School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies. The study will be done in accordance with the national ethical guidelines for biomedical and health research involving human participants- Indian Council of Medical Research (ICMR) guidelines (revised-2017) and guidelines of Helsinki declaration 2013. All the participants will be made to sign the written informed consent prior to the participation into the study. The participants will be taken from outpatient department and education campus of Manna Rachna International Institute of Research and Studies, Faridabad, Haryana.

Following identification of the participants through inclusion and exclusion criteria, a total of 42 subjects will be enrolled for the study. The sampling using randomization (Coin and toss method) will be done and the participants will be assigned alternatively into three groups with 14 participants in each group.

The interventional Group-A will be treated with Physiotherapy exercises and affirmations; Interventional Group-B will get  treated yoga asana with affirmation training and comparator Group-C  will be treated with physiotherapy with affirmation and yoga with affirmation on alternate day basis. The overall treatment will be offered in all the three groups will be for six weeks. The Group A and B will get intervention on alternate days while Group C will get alternate therapy proposed in Group A and Group B on alternate days for all the six weeks respectively. The subjects will be assessed at Day-0 for baseline data which will be the pre assessment data  and finally at Day-42 for the final post intervention assessment.

 

 

 
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