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Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

Primary Purpose

Premenstrual Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
NSAIDs or oral contraceptives treatment
Low dose acupuncture
High dose acupuncture
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Acupuncture, Premenstrual Syndrome, TCM syndrome

Eligibility Criteria

19 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

1.15 to 49 years 2.with a history of regular menstrual cycles (28days±7 days) 3.Symptoms:breast pain、dizziness、bloating、cramps、nausea、vomiting、 diarrhea、headache、 fatigue,etc

Exclusion Criteria:

  1. irregular menstrual cycles
  2. intrauterine contraceptive device (IUCD/IUD)
  3. uncontrolled neurological diseases
  4. lactation, pregnant women,or those with plans to get pregnant in the coming half year

Sites / Locations

  • Taipei City H

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional Gynecologic Treatment group

Low dose acupuncture group

High dose acupuncture group

Arm Description

Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.

Acupuncture has fewer acupuncture points.

Acupuncture has more acupuncture points.

Outcomes

Primary Outcome Measures

Wang Qi Chinese Medicine Questionnaire
This questionnaire is used to survey TCM constitutions. Evaluate body constitution of

Secondary Outcome Measures

Visual analogue scale(VAS) score
VAS is used to assess the extent of menstrual pain.
Blood test estrogen
Blood test progesterone
Blood test prostaglandin
Menstrual Distress Questionnaire(MDQ)
Contain: Pain;Concentration;Behavioral Change;Autonomic Reactions;Water Retention;Negative Affect

Full Information

First Posted
March 3, 2020
Last Updated
March 4, 2020
Sponsor
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04296422
Brief Title
Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis
Official Title
Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 18, 2020 (Anticipated)
Study Completion Date
September 18, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The design of the study includes 3 groups for women with premenstrual syndrome, 1low dose acupuncture in the low-dose group, 2 high dose acupuncture in the high-dose group, and 3 the drug group (contraceptives) . Serum marker change of PGE2, CA125, E2, and progesterone in enrolled patients will be measured before and after treatment, along with VAS and MDQ questionnaires. The treatment efficacy of different groups and the relationship between PMS and patients TCM syndrome pattern will also be recorded and estimated.
Detailed Description
Premenstrual syndrome (PMS) is the sum of a group of symptoms (including physical and psychological symptoms) that occurs during the luteal phase of the menstrual cycle. Women who have such symptoms have been estimated as high as 75%; of which 3% to 8% are severe symptoms, called premenstrual dysphoric disorder (premenstrualdysphoric syndrome, PMDD). The two groups are very similar. PMS is mostly for physical discomfort, while PMDD is for emotional problems, affecting women's sleep seriously. Regarding the treatment of premenstrual syndrome (PMS), western medicine adopt oral contraceptive pills (OCP) as the first-line medication. However, the common side effects of OCP, such as headache, dizziness, nausea, vomiting, depression, breast pain and so on are also troublesome, In recent years, some women also use acupuncture as an adjunctive replacement therapy because of its safety and fewer side effects. Nevertheless, the factors affecting treatment effect of acupuncture and moxibustion. such as the selection of acupoint s ( of which meridians) or number(dose) of acupuncture ,etc., maight affect the efficacy, yet the relevant research on this issue is not enough. In traditional Chinese medicine theory, acupuncture and moxibustion regulate the energy of the meridians and adjust blood and qi, which in turn help the balance of yin and yang. Female menstrual cycle is a process of conversion between yin and yang in TCM theory. While in western medicine, it is regulated by the endocrine system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Acupuncture, Premenstrual Syndrome, TCM syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Gynecologic Treatment group
Arm Type
Active Comparator
Arm Description
Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
Arm Title
Low dose acupuncture group
Arm Type
Experimental
Arm Description
Acupuncture has fewer acupuncture points.
Arm Title
High dose acupuncture group
Arm Type
Experimental
Arm Description
Acupuncture has more acupuncture points.
Intervention Type
Drug
Intervention Name(s)
NSAIDs or oral contraceptives treatment
Other Intervention Name(s)
Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
Intervention Description
Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
Intervention Type
Device
Intervention Name(s)
Low dose acupuncture
Intervention Description
Six acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6)
Intervention Type
Device
Intervention Name(s)
High dose acupuncture
Intervention Description
Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner
Primary Outcome Measure Information:
Title
Wang Qi Chinese Medicine Questionnaire
Description
This questionnaire is used to survey TCM constitutions. Evaluate body constitution of
Time Frame
Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days).
Secondary Outcome Measure Information:
Title
Visual analogue scale(VAS) score
Description
VAS is used to assess the extent of menstrual pain.
Time Frame
Change from Baseline VAS score at 4 cycles (each cycle is 30 days).
Title
Blood test estrogen
Time Frame
Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Title
Blood test progesterone
Time Frame
Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Title
Blood test prostaglandin
Time Frame
Change from Baseline blood test at 4 cycles (each cycle is 30 days).
Title
Menstrual Distress Questionnaire(MDQ)
Description
Contain: Pain;Concentration;Behavioral Change;Autonomic Reactions;Water Retention;Negative Affect
Time Frame
Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.15 to 49 years 2.with a history of regular menstrual cycles (28days±7 days) 3.Symptoms:breast pain、dizziness、bloating、cramps、nausea、vomiting、 diarrhea、headache、 fatigue,etc Exclusion Criteria: irregular menstrual cycles intrauterine contraceptive device (IUCD/IUD) uncontrolled neurological diseases lactation, pregnant women,or those with plans to get pregnant in the coming half year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsai-Ju Chien
Organizational Affiliation
Taipei City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi-Shuo Huang
Organizational Affiliation
Taipei City Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Taipei City H
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study will have a continuous plan.

Learn more about this trial

Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

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