| CTRI Number |
CTRI/2023/11/059639 [Registered on: 07/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Acupuncture for Dysmenorrhea |
|
Scientific Title of Study
|
Effect of selective acupuncture points on pain in patients with primary Dysmenorrhea - A Randomized controlled trail |
| 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 R JENIE |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (first floor), Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9790685767 |
| Fax |
|
| Email |
jeniedaniel1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Prabu |
| Designation |
Assistant Medical Officer/Grade II Lecturer |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (first floor), Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R JENIE |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (first floor), Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9790685767 |
| Fax |
|
| Email |
jeniedaniel1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr R JENIE |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(first floor) ,Kamarajar nagar, Chengalpattu. |
| Type of Sponsor |
Other [self] |
|
|
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 R JENIE |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block (first floor), Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU |
9790685767
jeniedaniel1996@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: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture for primary dysmenorrhea |
Acupuncture needling on P6, SP4, KI14, LIV3) once a day thrice a week for 3 months |
| Comparator Agent |
Sham acupuncture |
Sham acupuncture for 20 minutes once a day thrice a week for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Female |
| Details |
Females under age group of 18 to 28 years having dysmenorrhea since menarche and willing to give consent |
|
| ExclusionCriteria |
| Details |
Patients having underlying malignancy, infection or any underlying pathological condition.
needle phobia pregnant and lactating women.
patient who are not mentally stable |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of visual analogue scale,
Menstrual symptom questionnaire |
Baseline & 13th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of variation in C-Reactive protein level |
Baseline & 13th week |
|
|
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 2 |
|
Date of First Enrollment (India)
|
14/11/2023 |
| 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="1"
Days="1" |
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - online
- For how long will this data be available start date provided 14-11-2023 and end date provided 15-12-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Primary Dysmenorrhea is defined as cramping pain during menstruation without any identifiable pathology. It is a common gynecological complaint that can affect as many as 50% of women, 10% of these women suffer severely enough to render them incapacitated for one to three days in each menstrual cycle, Acupuncture, derived from China, is a therapeutic modality using the insertion of fine needles and manipulating them with manual, electrical, or other forms of stimulation. According to traditional and modern diagnosis, several points help to inhibit the inflammatory markers production leading to a reduced menstrual cramps. Penetrating Vessel is involved in all cases of Blood stasis in gynecological disorders. Kidneys as it originates in that area essence and it distributes Essence all over the body. Baseline assessments will be done before the onset of the study on the first day of menstruation. The post-assessments will be done after the completion of the 3 months intervention, on the first day of menstruation in the fourth month of the study. This Randomized control study will be conducted among 60 participants aged between 18 to 24 years randomly recruited from the residential college. Female participants satisfying the inclusion and exclusion criteria will be included in the study. The information about the study will be instructed to the subjects. After obtaining the written consent, the procedure of study will be carried out in the duration of 3 months. All the eligible subjects will be randomly divided into 2 groups. The study group will undergo needling (P6, SP4, KI14, LIV3) thrice a week followed for 3 months . While the control group will be given sham acupuncture for 20 minutes during the same time followed by 3 months . The study will assess Visual Analogue Scale (VAS), Menstrual Symptom Questionnaire (MSQ) and C-reactive protein before and after the intervention of 3 months. |