| CTRI Number |
CTRI/2025/02/081144 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of acupuncture on lipid profile in patients with abnormal blood cholesterol levels |
|
Scientific Title of Study
|
Effect of Acupuncture on lipid profile in patients with dyslipidemia-A Randomized placebo 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 E Pavithra |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, room no 2, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9087658552 |
| Fax |
|
| Email |
paviemailid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecturer grade 2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Research, Second floor,room no 4, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam,
Chennai-600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Pavithra |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Acupuncture and Energy Medicine, Second floor, room no 2, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai-600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9087658552 |
| Fax |
|
| Email |
paviemailid@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital,
Arumbakkam, Chennai |
| 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 E Pavithra |
Government Yoga and Naturopathy Medical College and Hospital |
Department of
Acupuncture and Energy
Medicine, Room no 2,
Second floor, Government
Yoga and Naturopathy
Medical College and
Hospital, PG block,
Arumbakkam,Chennai -106
Chennai
TAMIL NADU |
9087658552
paviemailid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E78||Disorders of lipoprotein metabolism and other lipidemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture needling |
The Participants will receive acupuncture on points including Ren-6 (Qihai), ST36 (Suzanli), BL23 (Shenshu), BL67 (Zhiyin), and K3 (Taixi). The needling
will be administered bilaterally (Except Ren 6) for 20 minutes daily for 2 weeks (totaling 14 sessions), in a
sitting position. |
| Comparator Agent |
placebo sham acupuncture |
The participants will receive superficial needling on non-acupuncture points (1cun in and around 1 cun in and around of BL 55, BL 56, BL57, GB 38, GB 39)for 20 mins daily for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1) Participants with systemic disorders (i.e. Coronary, respiratory, kidney, Gastro intestinal
mental disorders)
2) Hepatitis B and C
3) Pregnant women and lactating mothers
4) Needle phobia
5) Participants who had already engaged with other study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lipid profile |
Lipid profile will be assessed
before and after ( 2 Weeks) the intervention using a blood test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/03/2025 |
| 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="5"
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 - NO
|
|
Brief Summary
|
A randomized placebo controlled trial is adopted for the study where participants will be recruited based on eligibility and will be divided into study and control groups with 25 participants in each group. The study group will be given acupuncture ST36 (Suzanli), BL23 (Shenshu), BL67 (Zhiyin), and K3 (Taixi) bilaterally and Ren-6 (Qihai) for 20 minutes daily for 2 weeks (totaling 14 sessions), in a sitting position. The control group will receive placebo acupuncture with moxibustion on non-acupuncture points (1 cun in and around of BL 55, BL 56, BL57, GB 38, GB 39) for the same duration as in the study group. Lipid profile will be measured before the intervention on Day 1 and Day 14 for both the study and control groups. |