| CTRI Number |
CTRI/2025/12/099501 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to see whether Scalp Acupuncture can improve breathing in people with Bronchial Asthma |
|
Scientific Title of Study
|
Clinical Evaluation on the Effect of Scalp Acupuncture Targeting the Thoracic Cavity Area Based on Pulmonary Functions in Individuals with Bronchial Asthma- 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 Benazir A |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Branch-3, Department of Acupuncture and Energy Medicine,Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9344751153 |
| Fax |
|
| Email |
benazirb984@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Geethanjali |
| Designation |
Head of the Department - Acupuncture (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Branch-3, Department of Acupuncture and Energy Medicine,Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6379377297 |
| Fax |
|
| Email |
drgeethu.nat007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Geethanjali |
| Designation |
Head of the Department - Acupuncture (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Branch-3, Department of Acupuncture and Energy Medicine,Kamarajar Nagar, Chengalpattu
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, Chengalpattu - 603001 |
|
|
Primary Sponsor
|
| Name |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Branch-3, Department of Acupuncture and Energy Medicine,Kamarajar Nagar, Chengalpattu-603001, Tamilnadu,India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Benazir A |
International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu |
184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty block, Ground floor, Branch-3, Department of Acupuncture and Energy Medicine,Kamarajar Nagar, Chengalpattu-603001
Kancheepuram
TAMIL NADU |
9344751153
benazirb984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scalp Acupuncture at Bilateral Thoracic Cavity Area |
The subjects will be receiving intervention on undergo sterile needling at Bilateral thoracic cavity area on scalp [ 4cm long line forwards and backwards from midway between the midpoint of pupil and anteroposterior midline at the natural hair line]. 0.25 mm × 40 mm needle, inserting at a 15–30-degree angle at a depth of 1.5 tsun for 30 minutes without subjecting to any type of hand or electrical stimulation for 3 sessions in a week, for 18 sessions for 6 weeks. |
| Comparator Agent |
Under routine care |
In a control group participants will not receive any acupuncture intervention. They will remain seated comfortably for 30 minutes under routine care.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age group: 18 years to 45 years
Both Gender (Male and Female)
Persons who are willing to give their consent
No acute exacerbation in past 2 to 4 weeks before recruitment
Mild to moderate persistent asthma
|
|
| ExclusionCriteria |
| Details |
Females during menstrual bleeding, pregnancy and lactation.
Other Respiratory disorders such as COPD, Pneumonia, Chronic bronchitis, Bronchiectasis, Pulmonary fibrosis, Tuberculosis. Chronic or systemic ailments such as cardiac, renal, hepatic, neurological, or psychological illness.
Severe or uncontrolled asthma, frequent exacerbations or hospitalizations in past 3 months.
Past history of surgery in last one year, Needle phobia, Smoking or alcohol abuse
Open wounds, burns or scalds in the scalp.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spirometry is one of the most readily available and useful tests for pulmonary function. Spirometry measures which include total exhaled volume (FVC), the volume exhaled in the first second (FEV1), and their ratio (FEV1/FVC) and Peak Expiratory Flow Rate (PEFR), Forced expiratory flow at 25 to 75% of FVC (FEF 25-75%) undertaken in accordance with standard guidelines (American Thoracic Society and European Respiratory Society criteria for lung function testing. |
Baseline, After each week of treatment, After 6 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulse oximetry enables monitoring of arterial oxygen saturation, Standardized Asthma Quality of Life Questionnaire and Asthma Control Test Scale and Asthma Impairment and Risk Questionnaire or Asthma symptoms and exacerbations questionnaire |
Baseline,After each week of treatment,After 6 weeks of treatment |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/01/2026 |
| 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="2"
Days="3" |
|
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 - NO
|
|
Brief Summary
|
Bronchial Asthma is a chronic respiratory disease characterized by airway inflammation and airway hyperresponsiveness and reversible airflow obstruction resulting from smooth muscle spasms in the walls of smaller bronchi and bronchioles. This Randomized Controlled Study aims to clinically evaluate the effects of Scalp Acupuncture targeting the Thoracic Cavity Area based on Pulmonary Functions in Individuals with Bronchial Asthma. 80 Eligible Participants will be randomly allocated into two groups. The Study Group will receive Scalp Acupuncture at Bilateral Thoracic Cavity Area defined as four centimeter line extending anteriorly and posteriorly from a point midway between the midpoint of pupil and the anteroposterior midline at the natural hairline. Sterile Disposable Filiform Needles will be retained for thirty minutes administered three sessions per week for eighteen sessions in six weeks. The Control Group will be observed without any Intervention. Primary Outcomes include Pulmonary Function Parameters assessed using spirometry and Secondary Outcomes includes Peripheral Oxygen Saturation and assessment of Asthma related Quality of Life Questionnaire. |