| CTRI Number |
CTRI/2024/06/068489 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Acupuncture and postmenopausal syndrome |
|
Scientific Title of Study
|
To Evaluate the efficacy of selective acupuncture points for post-menopausal symptoms - A Randomised Controlled trial |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR.KEERTHIKA.G |
| Designation |
P G SCHOLAR |
| 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.2, KAMARAJ NAGAR, CHENGALPATTU.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9384407904 |
| Fax |
|
| Email |
keerthikagobalan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.PRABU NARASIMMAN |
| Designation |
ASSISTANT MEDICAL OFFICER |
| 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.2, KAMARAJ NAGAR, CHENGALPATTU.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRABU NARASIMMAN |
| Designation |
ASSISTANT MEDICAL OFFICER |
| 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.2, KAMARAJ NAGAR, CHENGALPATTU.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566351891 |
| Fax |
|
| Email |
drprabubnys91@gmail.com |
|
|
Source of Monetary or Material Support
|
| INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES, FACULTY BLOCK, GROUND FLOOR, ROOM NO.2, KAMARAJ NAGAR, CHENGALPATTU- 603001. |
|
|
Primary Sponsor
|
| Name |
DR KEERTHIKA G |
| Address |
INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES, FACULTY BLOCK, GROUND FLOOR,
ROOM NO.2, KAMARAJ NAGAR,
CHENGALPATTU-603001. |
| 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 Keerthika G |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4, Acupuncture and Energy Medicine Division, Faculty Block, Ground Floor, Room N0.2, Kamaraj Nagar, Chengalpattu
Kancheepuram
TAMIL NADU |
9384407904
keerthikagobalan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committe, International Institute of Yoga and Naturopathy Medical Sciences Chengalpattu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N959||Unspecified menopausal and perimenopausal disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acupuncture |
The sterile Copper handled single use needles will be inserted by manual acupuncture technique, twice a week for 8 weeks with 30 minutes duration without any stimulation. The study group will be receiving acupuncture therapy as following methods. Heart rate variability, Anthropometric Measurements, Self-administered Menopause rating scale and Menopause specific quality of life questionnaire will assess before and after study period. |
| Comparator Agent |
Waitlist |
Subjects will not receive the intervention throughout the study period.
Heart rate variability, Anthropometric Measurements, Self-administered Menopause rating scale and Menopause specific quality of life questionnaire will assess before and after study period.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Post-menopausal women.
2. Age group: 45 - 55 years.(14)
3. Participants with Menopause Rating score greater than 4
|
|
| ExclusionCriteria |
| Details |
1. Iatrogenic menopause.
2. Hormonal amenorrhea.
3. Enrollment in other studies that involved active interventions.
4. Psychiatric co-morbidities & Needle phobia.
5. Participants with skin lesion, open wounds, scalds, burns in selective points.
6. Participants with other co-morbidities related with menopause.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HRV and MRS will be assessed before and after the intervention. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometric measurement and Quality of life will be assessed by self-administered Menopause-specific quality of life questionnaire before and after intervention. |
2 mothns |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="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
|
Menopause is defined as the
permanent cessation of menstruation resulting in the loss of ovarian follicle
development. It means that the release of eggs for fertilization by ovaries is
stopped. Natural menopause occurs between 45 and 55 years for women worldwide.
Some women may have attained menopause earlier before 40 years of age. Most of the women were
manage their symptoms. But about 15% of women need hormone replacement therapy,
psychotherapy. Hormone replacement therapy includes administration of estrogen
it will reverse the symptoms, but it has some own limitations. Acupuncture is system of
medical treatment based on the principle of Taoism. Under this ideology the
health is not merely an absence of disease it means that health is maintained
by balance between yin and yang which based on 5 element theory. This study focus on the selected
acupuncture points that nourish and tonify the kidney yin and calms the mind
(shen) through increasing level of parasympathetic activation of sinoatrial
node by vagus nerve and to reduce the symptomatic (climacteric) changes caused
by deficiency of kidney yin patterns that affects the daily activities of life
in post-menopausal women include KID -3 (TAIXI), HE -6 (YINXI), CV-4(GUANYOAN), KID -2 (RANGU). |