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CTRI Number  CTRI/2025/12/099733 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Acupuncture treatment for Anxiety disorder 
Scientific Title of Study   Effect of Back Shu Point of the Heart (BL-15 Bilateral) on Cardiac Autonomic Function among Individuals with Generalized Anxiety Disorder—A Randomized Controlled Trial 
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 Anbukalaiselvan M 
Designation  PG Scholor 
Affiliation  International Institute of yoga and Naturopathy Medical Sciences 
Address  184/4 International Institute of yoga and Naturopathy Medical Sciences Faculty block ground floor room no 3 Chengalpattu Kancheepuram

Kancheepuram
TAMIL NADU
603001
India 
Phone  8778370330  
Fax    
Email  ashanbu71082@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Geethanjali S 
Designation  Head of the Department (i/c) 
Affiliation  International Institute of yoga and Naturopathy Medical Sciences 
Address  184/4 International Institute of yoga and Naturopathy Medical Sciences Faculty block ground floor room no 3 Chengalpattu Kancheepuram

Kancheepuram
TAMIL NADU
603001
India 
Phone  6379377297  
Fax    
Email  drgeethu.nat007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geethanjali S 
Designation  Head of the Department (i/c) 
Affiliation  International Institute of yoga and Naturopathy Medical Sciences 
Address  184/4 International Institute of yoga and Naturopathy Medical Sciences Faculty block ground floor room no 3 Chengalpattu Kancheepuram

Kancheepuram
TAMIL NADU
603001
India 
Phone  6379377297  
Fax    
Email  drgeethu.nat007@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical Sciences Kamarajar Nagar Chengalpattu Kancheepuram Tamil Nadu 603001 India 
 
Primary Sponsor  
Name  Dr Anbukalaiselvan 
Address  184/4 International Institute of Yoga and Naturopathy Medical Sciences Faculty Block Ground Floor Room No 3 Department of Acupuncture and Energy Medicine Division III Kamaraja Nagar Chengalpattu 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Anbukalaiselvan M  International Institute of Yoga and Naturopathy Medical Sciences  184/4 Acupuncture and Energy Medicine Division III Faculty Block Ground Floor Room No 2 Kamarajar nagar Chengalpattu 603001
Kancheepuram
TAMIL NADU 		 8778370330

ashanbu71082@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee International Institute of Yoga and Naturopathy Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acupuncture  The Sterile copper needles (Tx Pinpai, single -u se) will be inserted bilaterally at BL -1 5 (Xin Shu), located 1.5 -c un lateral to the posterior midline at the level of the lower border of the spinous process of the 5th thoracic vertebra (T5). The needles will be inserted obliquely toward the spine at a depth of 0.5 –1 cun . During inte rvention, the patients will remain in the prone position for 20 minutes per session, three times per week, for four weeks . 
Comparator Agent  Waitlisted  The control group will rest in a prone position for 20 minutes without any intervention and follow their usual routine, and they will receive the treatment after the entire study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Participants with a baseline Hamilton Anxiety Rating Scale HAMA score of greater than or equal to 18 aged between 18 and 35 years of either gender who are willing to participate in the study and who have experienced anxiety symptoms for at least three months prior to enrollment were included 
 
ExclusionCriteria 
Details  Participants with a history of cardiovascular diseases, known allergies to needles or needle phobia, a history of depression or trauma, pregnant or lactating women, individuals who consume alcohol or tobacco, and those currently undergoing treatment for anxiety or requiring medical attention were excluded from participation. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Heart Rate Variability(HRV)  1 Month
 
 
Secondary Outcome  
Outcome  TimePoints 
Generalized Anxiety Disorder Questionnaire (GAD -7 )
Blood pressure (BP)
pulse rate (PR) 		 1 Month 
 
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)   08/01/2026 
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="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashanbu71082@gmail.com].

  6. For how long will this data be available start date provided 20-10-2027 and end date provided 20-10-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A randomized controlled trial designed to evaluate the effectiveness of acupuncture at the Heart Back Shu point (BL15 bilaterally) in improving cardiac autonomic function and reducing anxiety in individuals with Generalized Anxiety Disorder (GAD). Recognizing the global burden of anxiety and its association with autonomic dysregulation and cardiovascular risk, the study proposes to assess changes in Heart Rate Variability (HRV), GAD-7 anxiety scores, blood pressure, and pulse rate following four weeks of BL15 acupuncture compared to a control group resting in a prone position. Ninety participants aged 18–35 with moderate to severe anxiety will be randomly allocated into study and control groups, with interventions administered three times weekly. This study aims to scientifically establish whether BL15 stimulation can serve as a safe, non-pharmacological method to modulate autonomic balance and alleviate anxiety symptoms. 
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