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CTRI Number  CTRI/2024/03/064650 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 11/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Yoga, Pranayama]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pranayama and Parkinsons Disease  
Scientific Title of Study   Effect of Pranayama on non-motor symptoms in patients with Parkinsons disease.  
Trial Acronym  n/a 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHREYA VERMA 
Designation  Senior Resident 
Affiliation  VMMC and SJH 
Address  Neurology ward 16, 8th floor, SSB building, VMMC and SJH, Ansari Nagar
New Delhi
South
DELHI
110029
India 
Phone  7980886258  
Fax    
Email  dr.shreyaverma125@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. B.K. Bajaj 
Designation  Director Professor and HOD 
Affiliation  VMMC and SJH 
Address  Neurology Office, 8th floor, SSB building, VMMC and SJH, Ansari Nagar
New Delhi
South
DELHI
110029
India 
Phone  9968443100  
Fax    
Email  docbajaj@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  SHREYA VERMA 
Designation  Senior Resident 
Affiliation  VMMC and SJH 
Address  Neurology Office, 8th floor, SSB building, VMMC and SJH, Ansari Nagar
New Delhi
South
DELHI
110029
India 
Phone  7980886258  
Fax    
Email  dr.shreyaverma125@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital, New Delhi 
 
Primary Sponsor  
Name  VMMC and Safdarjung Hospital 
Address  Ansari Nagar, New Delhi 110029 
Type of Sponsor  Government medical college 
 
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 
Dr Shreya Verma  VMMC and Safdarjung hospital  Neurology Ward 16, 8th floor, SSB building, VMMC and SJH, Ansari Nagar
South
DELHI 
7980886258

dr.shreyaverma125@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhaman Mahavir Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group, Group 2  No intervention 
Intervention  YOGA, PRANAYAMA  Pranayama Protocol for Intervention Group 1. Anulom Vilom- Alternate nostril breathing for 10 minutes 2. Kapalbhati- Long inhalation followed by rapid exhalation and relaxion for 10 minutes 3. Bhramari- Taking deep breaths in and as while gently pressing the cartilage on ears with index fingers and making a loud humming sound for 10 minutes 4. Bhrastika- Long breaths followed by rapid forceful exhalation with alternate opening and closing fist for 10 minutes. Practiced for a total of 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Hoer and Yahr stage 1 to 3 
 
ExclusionCriteria 
Details  patients with other neurological comorbidities or significant drugs affecting CNS or patients who cannot perform Pranayama or Pregnant women 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in non motor symptoms in patients with Parkinsons disease on stable treatment after 12 weeks of Pranayama   12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in P300 latencies, PDQ39 scores  12 weeks 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/04/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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  
There is paucity of literature on the impact of Pranayama on patients with Parkinson’s Disease. All the eligible patients giving written informed consent will undergo baseline evaluation of motor and non-motor functions. Motor function rating will be done by Clinician rated validated MDS UPDRS Part Ill scale. Non motor symptom scale will be administered by the trained investigator. All patients will be evaluated with Montreal Cognitive Assessment Scale, Frontal Assessment Battery and their baseline quality of life will be measured using Parkinson’s Discase Quality of Life instrument, PDO-39. Cognitive evoked potential P300 will be recorded in all the patients at baseline. The P300 component, of cognitive potential, is a positive potential elicited by the recognition of a rare stimulus (oddball paradigm) within a series of frequent stimuli and corresponds to the largest positive wave after the N1-P2 complex. Odd Ball paradigm will be used for recording the P300 with recording electrode placed over centroparieral area as per the 10-20 system of electrode placement and the reference electrode being the ear lobes. Low frequency Filter and High Frequency Filter will be set at 0.01 Hz and 100 Hz respectively with sweep speed. A detailed proforma as per the
annexure regarding the patient’s clinical details will be filled and details of the dose and duration of each of the medicines being taken will be entered. Equivalent levodopa dose will be calculated for each of the patients. The patients will be randomly allocated to one of the 2 groups: the Pranayama group and the Control group. The Control group will continue to get standard anti parkinsonian medicines and the Pranayama group will practice the Pranayama Protocol as per the annexure. The intervention group will be taught 4 Pranayama- Anulom Vilom, Kapalbhati, Bhramri and Bhrastika for around a week by trained personnel. Instructions will be given at the hospital initially and once it is ascertained that the patient and their primary care giver if available have learnt the technique, patients will be instructed to undertake the Pranayama at home at least once a day and at least 5 times a week. All the patients in the Pranayama group will be encouraged to do Pranayama twice a day (once in the morning and once in the evening). All the patients/ caregiver will record the date/day and duration of Pranayama undertaken each day. The immediate caregiver or family member will be requested to assist and monitor the patient’s performance of the Pranayama. The records of the performance of the Pranayama will be received telephonically every fortnightly and patient/ family member will be asked to report any specific issues encountered for appropriate action and suggestions as required.
Patients and caregivers will be requested to make a video of the performance of pranayama and share on a mobile number given to him/her if required. If any difficulty or incorrect performance of the Pranayama is noted, appropriate instructions will be given again, by video call or physical mode as required and feasible. If any difficulty in performing or observed to be incorrectly performing the Pranayama, will be given instructions again, by video call or physical mode as required or feasible. Follow up visit will be after 12 weeks. At 12 week follow up visit, patients will be revaluated with repeat MDS UPDRS Part III, on motor symptom scale score, MoCA (Montreal cognitive assessment score), FAB (Frontal assessment battery), Cognitive Evoked Potential P300, HAM-A and HAM-D (Hamilton scales for anxiety and depression) and PDQ 39 (Parkinson’s disease quality of life index). Change in scores will be recorded statistical analysis will be performed on the data collected.
 
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