Different Does of Acupuncture on Premenstrual Syndrome Efficacy Analysis

NCT04296422 | Unknown

• 1 other identifier: TCHIRB-10712111
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

Acupuncture; Premenstrual Syndrome; TCM syndrome

Outcome Measures

Primary Outcomes (1)

• Wang Qi Chinese Medicine Questionnaire

  This questionnaire is used to survey TCM constitutions. Evaluate body constitution of

  Change from Baseline TCM constitutions at 4 cycles (each cycle is 30 days).

Secondary Outcomes (5)

• Visual analogue scale(VAS) score

  Change from Baseline VAS score at 4 cycles (each cycle is 30 days).

• Blood test estrogen

  Change from Baseline blood test at 4 cycles (each cycle is 30 days).

• Blood test progesterone

  Change from Baseline blood test at 4 cycles (each cycle is 30 days).

• Blood test prostaglandin

  Change from Baseline blood test at 4 cycles (each cycle is 30 days).

• Menstrual Distress Questionnaire(MDQ)

  Change from Baseline Menstrual Distress Questionnaire at 4 cycles (each cycle is 30 days).

Study Arms (3)

Conventional Gynecologic Treatment group

ACTIVE COMPARATOR

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

Drug: NSAIDs or oral contraceptives treatment

Low dose acupuncture group

EXPERIMENTAL

Acupuncture has fewer acupuncture points.

Device: Low dose acupuncture

High dose acupuncture group

EXPERIMENTAL

Acupuncture has more acupuncture points.

Device: High dose acupuncture

Interventions

NSAIDs or oral contraceptives treatment DRUG

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

Also known as: Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.

Conventional Gynecologic Treatment group

Low dose acupuncture DEVICE

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

Low dose acupuncture group

High dose acupuncture DEVICE

Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner

High dose acupuncture group

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei City Hospital: lead

Study Sites (1)

Taipei City H

Taipei, Taiwan

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Naproxen; Diclofenac; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Complementary Therapies; Therapeutics

Study Officials

• Tsai-Ju Chien

  Taipei City Hospital

  PRINCIPAL INVESTIGATOR

• Yi-Shuo Huang

  Taipei City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: January 1, 2019
• Primary Completion: September 18, 2020
• Study Completion: September 18, 2020
• Last Updated: March 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)