The Efficacy of Different Doses of Acupuncture in Dysmenorrhea

NCT03881319 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2019-03-19

No results posted yet for this study

Summary

Subjects in this study included premenstrual syndrome and dysmenorrhea.

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. Dysmenorrhea is a sort of period pelvic pain, caused by blood flow decrease abruptly and ischemia due to frequent contraction of the uterus.

In clinical practice, gynecologists apply analgesic such as Non-steroidal Anti- inflammatory Drugs (NSAIDs), and oral contraceptive pills (OCT) or progestin as conventional therapy for premenstrual syndrome and dysmenorrhea. As NSAIDs may cause gastrointestinal discomfort, dyspepsia while hormone therapy leads to other concerns; some women now adopt acupuncture as an alternative therapy for its safety. However, many parameters affect the efficacy of acupuncture, such as the sorts of acupoints (of which meridians) or the numbers of acupoints; and proper evidence-based medicine on this issue is few.

Therefore, in this study, we aim to evaluate 1. The different impact of acupuncture and conventional therapy in premenstrual syndrome and dysmenorrhea women ; 2. Will the character (of which meridians) or numbers of acupoints be affecting factors of efficacy in treating premenstrual syndrome and dysmenorrhea? 3. Shall there be any relationship between the acupuncture and autonomic nerve activity adjustment in premenstrual syndrome and dysmenorrhea? 4. Shall there be any relationship between the acupuncture and TCM syndrome adjustment in premenstrual syndrome and dysmenorrhea?

Conditions

  • Premenstrual Syndrome
  • Dysmenorrhea

Interventions

DRUG

Conventional gynecologic treatment

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

DEVICE

Low dose acupuncture

Six acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6)

DEVICE

High dose acupuncture

Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner Pass(PC6) 、Supreme Rush(LR3) 、Joining Valley(LI4) 、Supreme Stream(KI3) 、Uterus(EX-CA1) 、Leg Three Miles(ST36)

Sponsors & Collaborators

  • Taipei City Hospital

    lead OTHER_GOV

Principal Investigators

  • Tsai-Ju Chien, PhD degree · Taipei City Hospital

  • Yi-Shuo Huang, B.S. degree · Taipei City Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881319 on ClinicalTrials.gov