Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743218
Status:
RECRUITING
Last Update Posted:
2023-02-24
First Post:
2023-01-12
Brief Title:
Clinical Efficacy of Acupuncture on the Liver Meridian in Women With Diminished Ovarian Reserve
Sponsor:
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Organization:
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Study Overview
Official Title:
Clinical Study of Liver Meridian in the Treatment of Male Impotence and Female Premature Ovarian Failure
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GJZLLCCBGNXJ
Brief Summary:
Diminished ovarian reserve DOR refers to a decrease in the number and quality of oocytes in the ovary which results in impaired ovarian function and decreased fertility Meanwhile levels of the anti-Müllerian hormone AMH antral follicle count AFC and Follicle-Stimulating Hormone FSH also decrease in patients with DOR In general there is a decline in fertility and premature menopause Some patients will have low menstrual volume oligomenorrhea or even amenorrhea abnormal uterine bleeding ovulation disorders infertility and perimenopausal performance before the age of 40 and eventually develop into premature ovarian failure In recent years with the changes of social culture living environment work pressure and other factors the incidence of this disease has increased year by year which has a great impact on womens fertility mental health quality of life family relations and other aspects
As a green and safe complementary and alternative therapy acupuncture has been proved to be effective According to the statistics 904 3354 of the 2695 syndromes indicated by acupoints of the liver meridian recorded in 93 ancient medical books are reproductive disorders ranking first in the diseases indicated by the liver meridian and the 14 meridians The body surface course of the liver meridian is closely related to the genitals and there is a close relationship between the liver meridian and the genitals in physiology and pathology According to the theory of the relationship between meridians and zangfu organs the study aims to verify the efficacy and safety of acupuncture of the liver meridian and provide high-level research evidence for meridian syndrome differentiation of reproductive system diseases via treatment from the liver
As a green and safe complementary and alternative therapy acupuncture has been proved to be effective According to the statistics 904 3354 of the 2695 syndromes indicated by acupoints of the liver meridian recorded in 93 ancient medical books are reproductive disorders ranking first in the diseases indicated by the liver meridian and the 14 meridians The body surface course of the liver meridian is closely related to the genitals and there is a close relationship between the liver meridian and the genitals in physiology and pathology According to the theory of the relationship between meridians and zangfu organs the study aims to verify the efficacy and safety of acupuncture of the liver meridian and provide high-level research evidence for meridian syndrome differentiation of reproductive system diseases via treatment from the liver
Detailed Description:
This is an exploratory multicenter randomized controlled trial involving four clinical research centers including the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine Hubei Hospital of Traditional Chinese Medicine Shaanxi Hospital of Traditional Chinese Medicine and Guizhou Hospital of Traditional Chinese Medicine Each clinical research center strictly screened cases according to the diagnostic criteria inclusion criteria and exclusion criteria After confirmation of enrollment random numbers were obtained according to the application for random coding process until the total number of observation was completed According to the sample size a total of 198 patients with DOR need to be enrolled The 29-week study period consists of a 4-week screening period 1-week baseline period 12-week treatment period 12-week follow-up period and assessments at baseline He patients were randomly divided into three groups the liver meridian stomach meridian and non-acupoint acupuncture groups Due to the particularity of acupuncture research it is impossible to blind acupuncture operators Blinded evaluation will be adopted in the trial and the third party who does not know the grouping will evaluate the efficacy Blind statistical analysis was used in the data summary stage and the researchers operators and statisticians were separated In the experimental group liver meridian group EA was applied to Taichong Li gou Ququan and Jimai In the control group 1 gastric meridian group EA was applied to Chongyang Fenglong Zusanli and Biguan In the control group 2 the non-meridian non-acupoint group 4 non-meridian non-acupoints were selected from the lateral thigh the lateral calf and the lateral calcaneus respectively see the treatment methods of the non-meridian non-acupoint group for details and stimulated with EA
The main evaluation index will be Anti-Müllerian hormoneAMH The secondary evaluation index include serum sex hormones bFSH bE2 bLH bFSHbLH antral follicle countAFC menstrual status the modified Kupperman IndexKI perimenopausal quality of life score MENQOL Self-Rating Anxiety Scale SAS self-rating depression scaleSDS Menstrual conditions The patients were evaluated at different time points during the baseline period treatment period and follow-up period and the incidence of adverse events will be recorded Double data entry will be used in this trial to ensure the accuracy of data entry A three-level quality control system self-inspection by each center supervision by project management team and third-party audit was implemented to ensure that the implementation recording and reporting of clinical trials were in accordance with the trial protocol standard operating procedures and relevant laws and regulations The statistical analysis plan was developed by the statistical analysis principal and the principal investigators in accordance with the protocol and was finalized before the database was locked The tables for the statistical analysis were developed Statistical analysis will be calculated by SPSS250 statistical analysis software P005 ie 005 will be considered statistically significant in order to clarify the efficacy and safety of acupuncture on DOR
The main evaluation index will be Anti-Müllerian hormoneAMH The secondary evaluation index include serum sex hormones bFSH bE2 bLH bFSHbLH antral follicle countAFC menstrual status the modified Kupperman IndexKI perimenopausal quality of life score MENQOL Self-Rating Anxiety Scale SAS self-rating depression scaleSDS Menstrual conditions The patients were evaluated at different time points during the baseline period treatment period and follow-up period and the incidence of adverse events will be recorded Double data entry will be used in this trial to ensure the accuracy of data entry A three-level quality control system self-inspection by each center supervision by project management team and third-party audit was implemented to ensure that the implementation recording and reporting of clinical trials were in accordance with the trial protocol standard operating procedures and relevant laws and regulations The statistical analysis plan was developed by the statistical analysis principal and the principal investigators in accordance with the protocol and was finalized before the database was locked The tables for the statistical analysis were developed Statistical analysis will be calculated by SPSS250 statistical analysis software P005 ie 005 will be considered statistically significant in order to clarify the efficacy and safety of acupuncture on DOR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None