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CTRI Number  CTRI/2024/07/069698 [Registered on: 01/07/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Dinacharya Procedure-Abhyanga]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of Sesame Oil Massage on Strength of Individuals of age group 18 to 30 years undergoing Regular Fitness Training in Gym. 
Scientific Title of Study   Clinical Trial to Evaluate the Balya Effect of Tila Taila Abhyanga among Individuals undergoing Regular Fitness Training. 
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 Nilesh Suryakant Sanas 
Designation  PG Scholar, Department of Swasthavritta 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Department of Swasthavritta, OP No- 2,Government Ayurveda Panchakarma Hospital, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695012
India 
Phone  8380047448  
Fax    
Email  sanasnilesh157@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilesh Suryakant Sanas 
Designation  PG Scholar, Department of Swasthavritta 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Department of Swasthavritta, OP No- 2,Government Ayurveda Panchakarma Hospital, Thiruvananthapuram, Kerala, India


KERALA
695012
India 
Phone  8380047448  
Fax    
Email  sanasnilesh157@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyothi R 
Designation  Professor, Department of Swasthavritta 
Affiliation  Government Ayurveda Medical College and Hospital, Thiruvananthapuram 
Address  Department of Swasthavritta, OP No- 2,Government Ayurveda Panchakarma Hospital, Thiruvananthapuram, Kerala, India

Thiruvananthapuram
KERALA
695012
India 
Phone  9496291355  
Fax    
Email  drjyothisajeev@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College and Hospital,Thiruvananthapuram 695001, Kerala India 
 
Primary Sponsor  
Name  Dr Nilesh Suryakant Sanas 
Address  PG Scholar, Govt Ayurveda Medical College and Hospital,Thiruvananthapuram 695001 Kerala India 
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 
Dr Nilesh Suryakant Sanas  Government Ayurveda Panchkarma Hospital, Poojappura, Thiruvananthapuram  Department of Swasthavritta, OP No- 2,Government Ayurveda Panchakarma Hospital, Thiruvananthapuram, Kerala, 695012 India
Thiruvananthapuram
KERALA 		 8380047448

sanasnilesh157@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE(IEC),Govt ayurveda college,Thiruvanathapuram,Kerala,India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  To enhance the strength of individuals undergoing regular fitness training.  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Exercise for minimum 40 minutes for 30 days in Gym., Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charak Samhita Sutrasthanam 5/86-89, Procedure details: Slight heat the Sesame oil upto it gets luke warm. The oil heated should be applied uniformly. Start massaging scalp, head and move down to neck, upper back, shoulders, upper arms, forearms & hands then chest, abdomen, low back, lower limbs. Back should be massaged in upward down direction. Limb joints should be massaged in a circular manner and muscles in a linear manner. Umbilical region is massaged in circular manner. Participant should take rest for 10 minutes Bath in luke warm water with suitable medicated soap. Sesame oil massage should be done for 15-20 minutes daily for a period of 30 days. The participants should do exercise daily for minimum 40 minutes for a period of 30 days in gym before sesame oil massage.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Participants of the age group 18 to 30 years were enrolled irrespective of sex,caste or religion.
Participants doing daily a minimum of 40 minutes of workout in gym as a part of regular fitness training for 5 days in a week.
Participants willing to give consent.
Participants having BMI below 29.9 kg/m2. 
 
ExclusionCriteria 
Details  Participants suffering from acute injuries.
Participants who are contraindicated for Abhyanga.
Participants taking extra supplements for enhancing performance and endurance. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Sesame Oil Massage on Strength of individuals undergoing regular fitness training in gym by using Harvard step test, Sit-up test and Push-up test.  0th, 31st, 61st day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Tila Taila Abhyanga on Muscular Endurance.   0th, 31st, 61st day 
 
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/ Phase 4 
Date of First Enrollment (India)   11/07/2024 
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)   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  
Exercise is of great importance for maintaining good physical and mental health. Nowadays people of all sexes prefer going to gym for maintaining their physical fitness. Gyms are equipped with a 
wide range of exercise machines, free weights and other fitness equipment that may not be readily available at home. 
Ayurveda emphasizes on preventive healthcare through Dinacharya, Rithucharya, Achara rasayana, Vyayama mentioned in Ayurveda Swasthavritta play an important role in health promotion & prevention of diseases. Abhyanga is mentioned as one of the daily regimen for having a healthier life. Ayurveda explains the importance of doing daily abhyanga as it wards off old age, exertion, aggravation of vata, bestows good vision, nourishment, long life, good sleep, good and strong skin. Acharya Sushruta mentioned that abhyanga enhances the Bala i.e. strength and endurance. In people going to Gym, they undergo daily wear and tear, fatigue and exertion due to heavy physical activity. As daily abhyanga helps this individual to reduce their fatigue, exertion and give strength & flexibility to the body and making them stronger to tolerate this daily exercise and exertion. Gym-goers often experience muscle tension and tightness due to strenuous workouts. Abhyanga can release muscle knots, reduce muscle spasms, and improve overall muscle flexibility and smoothness. Abhyanga improves blood circulation throughout the body, this can aid in muscle repair and growth and contribute to overall fitness. This study is being made to highlight the application of these Ayurveda Dinacharya procedure called abhyanga on the Bala of this gym going individuals.
Individuals of age group 18-30 years going to gym as per inclusion and exclusion criteria will be selected from the gyms present in Thiruvananthapuram city and they are instructed to follow the Dinacharya measure called abhyanga with Tila taila daily after workout and before bath for 15-20 minutes continuously for 30 consecutive days. The findings for Balya effect of Abhyanga will be recorded in a structured clinical proforma before and after the study by using Harvard step test, Sit-up test and Push-up test and data collected will be processed and conclusion will be made accordingly.
 
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