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CTRI Number  CTRI/2024/06/068549 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of Foot Massage with oil and Bhramari Pranayama in sleeplessness among the people of 30 to 60 years  
Scientific Title of Study   Study to evaluate the effect of Padabhyanga and Bhramari Pranayama in Insomnia among the Middle-Aged People 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijeta Raghuwanshi 
Designation  Post Graduate Scholar 
Affiliation  Pt. Khushilal Sharma Government (Autonomous) Ayurvrda College and Institute,Bhopal,  
Address  Pt. Khushilal Sharma Government (Autonomous) Ayurvrda College and Institute,Bhopal, Science Hills, Nehru Nagar Kolar Bypass Road, Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  9926670841  
Fax    
Email  raghuwanshivijeta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitin Marwaha 
Designation  Professor 
Affiliation  Pt. Khushilal Sharma Government (Autonomous) Ayurvrda College and Institute,Bhopal 
Address  Pt. Khushilal Sharma Government (Autonomous) Ayurvrda College and Institute,Bhopal, Science Hills, Nehru Nagar Kolar Bypass Road, Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  9425377177  
Fax    
Email  marwahaayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nitin Marwaha 
Designation  Professor 
Affiliation  Pt. Khushilal Sharma Government (Autonomous) Ayurvrda College and Institute,Bhopal 
Address  Pt. Khushilal Sharma Government (Autonomous) Ayurvrda College and Institute,Bhopal, Science Hills, Nehru Nagar Kolar Bypass Road, Bhopal


MADHYA PRADESH
462003
India 
Phone  9425377177  
Fax    
Email  marwahaayu@gmail.com  
 
Source of Monetary or Material Support  
Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute,Science Hills, Nehru Nagar- Kolar Bypass Road, Bhopal, 462003(M.P.) India 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal 
Address  Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute, Bhopal, Science Hills, Nehru Nagar Kolar Bypass Road, Bhopal 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijeta Raghuwanshi  Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute  Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute, Room No.8, Swathvritta and Yoga Department, Bhopal
Bhopal
MADHYA PRADESH 		 9926670841

raghuwanshivijeta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute, Bhopal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Roasted Semolina1 gm roasted semolina in capsule form at night prior to bed- 2 capsules of 500 mg each
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग EkA~gga (Procedure Reference: Charak Samhita and Hathyogapradeepia, Procedure details: Padabhayanga with 15 ml Til Taila at night prior to bed & Bhramari Pranayama 10 counts (10) minutes early in the morning & prior to bed)
(1) Medicine Name: Til Taila, Reference: Sharangdhar Samhita , Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: hs, Duration: 30 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects aged between 30 – 60 years irrespective of their caste, race and sex etc.
Patients having symptoms of Nidranash (Insomnia) described in Ayurvedic and Modern literature.
Patients of Insomnia with mild hypertension, mild depression and anxiety disorder without any other major disorder.
Patients willing to fill informed consent form. 
 
ExclusionCriteria 
Details  Age below 30 and above 60 years.
Patients of fatal familial Insomnia.
Patients with known case of Diabetes Mellitus, Malignancy, Bronchial Asthma, Foot ulcer, Benign Prostate Hypertrophy, Psoriasis, Chronic Renal Failure and other systemic diseases
Arthritis with severe pain.
Patients suffering from Middle ear infection.
People working in night shifts and people working in different time zone.
Patients having acute illness like Cardio-vascular accidents, Myocardial infarction and COPD.
Patients with alcohol and drug dependency. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study we would be able to assess the efficacy of Padabhyanga and Bhramari Pranayama in the management of Insomnia among middle- aged people by assessing the sleep quality of subjects with the help of Pittsburgh Sleep Quality Index and degree of Insomnia by Insomnia Severity Index before and after treatment  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   07/09/2024 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Sleep is one of the most significant human behaviour occupying roughly one-third of life. International Classification of Sleep Disorders-2 (ICSD-2) defined Insomnia as repeated difficulty with sleep initiation, duration, consolidation or daytime impairment. In Ayurveda Nidra has been explained as one of the upstambhas (triad) for sustaining life. In Ayurvedic literature Insomnia is explained by the term “Nidranash” or “Aswapna”. Padabhyanga as a part of dincharya is said to induce sound sleep. Bhramari is one of the eight Pranayamas mentioned in Hathyogpradipika.
The study design is Randomized Controlled Clinical Study and sample will be selected by Simple Random Sampling method. Preffered age group is 30-60 years. Sample size will be 60 divided into study group and control group. Participants of study group will be intervened with Padabhyanga by Til Taila prior to bed and Bhramari Pranayama 10 counts in the morning and prior to bed. Participants of control group will be given 1 gm roasted semolina in capsule form prior to bed. Total intervention period will be of 30 days. The study will be conducted on the patients of OPD and IPD of Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal. At the end of the study we would be able to assess the efficacy of Padabhyanga and Bhramari Pranayama in the management of Insomnia among middle-aged people.
 
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