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CTRI Number  CTRI/2025/08/093765 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga and Acupuncture for Improving Life with in Diabetic Women 
Scientific Title of Study   Synergistic Effects of Yoga And Acupuncture on Glycemic Management and Overall Well-Being in Diabetic Women 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saravana Pandiyaraja C 
Designation  Scholar 
Affiliation  Meenakshi Academy of Higher Education And Research 
Address  Dept. Faculty of Yoga Science and Therapy Division: 3 rd Flood Room No : 303 No : 12 Vembuliamman Koil Street west KK Nagar Chennai

Chennai
TAMIL NADU
600078
India 
Phone  8883833933  
Fax    
Email  acuhealercspraja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P Malaialagu  
Designation  Assistant Professor 
Affiliation  Meenakshi Academy of Higher Education And Research 
Address  Physical Education and Sports Meenakshi Academy of Higher Education And Research No: 12 Vembuliamman Koil Street west KK Nagar Chennai

Chennai
TAMIL NADU
600078
India 
Phone  9994206540  
Fax    
Email  Pmalaialagu@madch.edu.in  
 
Details of Contact Person
Public Query  
Name  Saravana Pandiyaraja C 
Designation  Scholar 
Affiliation  Meenakshi Academy of Higher Education And Research 
Address  Dept: Faculty of Yoga Science and Therapy Division: 3 rd Floor Room No: 303 No : 12 Vembuliamman Koil Street west KK Nagar Chennai

Chennai
TAMIL NADU
600078
India 
Phone  8883833933  
Fax    
Email  acuhealercspraja@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Saravana Pandiya Raja C 
Address  Dept: Faculty of Yoga Science and Therapy Division: 3rd Floor room No: 303 No 12 Vembuliamman Koil Street West KK Nagar Chennai 600078 Tamilnadu India 
Type of Sponsor  Other [ Self (Ph.D Scholar)] 
 
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 P Malaialagu  Meenakshi Academy of Higher Education and Research  Dept: Faculty of Yoga Science and Therapy Division: 3rd Floor Room No: 303 No: 12 Vembuliamman Koil Street West K K Nagar Chennai 600078 India
Chennai
TAMIL NADU 		 9994206540

Pmalaialagu@madch.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Meenakshi Academy of Higher Education and Research Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Yogic Practices with Acupuncture  Asana Pranayama Meditation along with Acupuncture Point like ST25, ST36, CV12, LI4, PC6, LR2 would be given for 5days per week. Duration 3 months 
Intervention  Yogic Practices without Acupuncture  Asana Pranayama Meditation would be given for 5days per week. Duration 3 months 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Middle adulthood women aged 40 to 60 years with diabetic symptoms residing in and around Karaikudi Sivagangai District

Willingness to participate in the study and signing the written consent form

Diagnosed with diabetes based on fasting blood glucose 126 mg per dL or greater or 7.0 mmol per L or if HbA1c is 6.5 or greater or 48 mmol per mol as per WHO guidelines

No recent engagement in yoga or acupuncture therapy

Assessed suitable for practicing yoga therapy based on physical exam

Individuals diagnosed with diabetes and currently on anti diabetic medication 
 
ExclusionCriteria 
Details  Women younger than 40 years or older than 60 years

Women who have serious diabetes-related complication heart problems or other long-term illnesses that could interfere with yoga or acupuncture

Women who are pregnant breastfeeding or who have joint/muscle problems or physical disabilities that make yoga practice difficult

Women who are already practicing yoga acupuncture or other alternative therapies that may affect the study results

Women with mental health or brain-related conditions that could affect participation

Women who do not provide consent to join the study 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
What: FBG (Fasting blood glucose) PPBG (post-prandial blood glucose) HbA1c
When: Pre and Post Intervention 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
SBP (systolic BP) DBP (Diastolic BP) Body Mass Index (BMI)
Mindfulness Attention Awareness Scale (MAAS) and Rosenberg Self Esteem Scale (RSES) Questionnaire
 		 3 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/09/2025 
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="3"
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  
This study would be conducted for the partial fulfilment of the PhD study at Meenakshi Academy of Higher Education and Research Chennai

Type 2 Diabetes Mellitus is a long-term metabolic disorder caused by insulin resistance, high blood sugar, and related complications. Women between 40 and 60 years are more vulnerable due to hormonal changes, obesity, stress, and sedentary lifestyles. Standard medical treatments often have side effects, which increases interest in complementary approaches. Yoga has been shown to improve blood sugar control, heart health, and psychological well-being. Acupuncture, recognized globally, may also lower blood sugar and improve insulin function. Limited studies have tested their combined effects. This study aims to examine the effectiveness of yoga with acupuncture compared to yoga alone in women with Type 2 Diabetes. A randomized trial will include 90 participants with fasting blood sugar above 126 milligrams per deciliter or HbA1c above 6.5 percent. Two groups will be formed: yoga with acupuncture and yoga alone. The twelve-week program will measure outcomes in blood sugar, cardiovascular health, mindfulness, and self-esteem.
 
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