{
    "abstract": "Dangguijagyag-san, also known as Dangguishaoyao-san in Chinese and Toki-shakuyakui-san in Japanese, has been frequently used to treat symptoms associated with dysmenorrhea. The purpose of this trial is to evaluate the efficacy and safety of the herbal medicine, Dangguijagyag-san, relative to those of active control, Gamisoyo-san, and a placebo control for primary dysmenorrhea.\nThis protocol details a randomized, double-blind, parallel-group, multi-center, investigator-initiated, controlled trial evaluating treatment of primary dysmenorrhea. Two hundred and forty participants will be randomly divided into one of three groups: 1) the Dangguijagyag-san experimental group (EG) (n = 105), 2) the Gamisoyo-san active control group (ACG) (n = 30), and 3) the placebo control group (PCG) (n = 105). The interventions will be administered for two menstrual cycles, and the follow-up will be carried out for the following six menstrual cycles. The primary outcomes are difference in response rates between the EG and the ACG (non-inferiority comparison) and difference in changes from baseline in average pain intensity measured by the visual analogue scale between the EG and PCG (superiority comparison). The secondary outcomes are pain scores derived from pain assessment tools (verbal multidimensional scoring system, retrospective symptom scale, and short form McGill pain questionnaire), dosage of analgesics, pattern diagnosis questionnaires, and short form 36 health survey. Adverse events and vital signs will be checked at every visit, and laboratory tests will be performed for safety evaluation.\nThe results of this clinical trial will offer evidence for the efficacy and safety of Dangguijagyag-san for primary dysmenorrhea.\nClinical Research Information Service of Korea: KCT0003005.",
    "authors": [
        {
            "affiliation": "Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.",
            "firstname": "Hye Lin",
            "initials": "HL",
            "lastname": "Woo"
        },
        {
            "affiliation": "Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.",
            "firstname": "Hae Ri",
            "initials": "HR",
            "lastname": "Ji"
        },
        {
            "affiliation": "College of Pharmacy, Pusan National University, Busan, Republic of Korea.",
            "firstname": "Siin",
            "initials": "S",
            "lastname": "Kim"
        },
        {
            "affiliation": "College of Pharmacy, Pusan National University, Busan, Republic of Korea.",
            "firstname": "Hae Sun",
            "initials": "HS",
            "lastname": "Suh"
        },
        {
            "affiliation": "Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.",
            "firstname": "Kwan-Il",
            "initials": "KI",
            "lastname": "Kim"
        },
        {
            "affiliation": "Department of Korean Medicine Obstetrics & Gynecology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.",
            "firstname": "Jin Moo",
            "initials": "JM",
            "lastname": "Lee"
        },
        {
            "affiliation": "Jaseng Hospital of Korean Medicine, 536 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea.\nJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 538 Gangnam-daero, Gangnam-gu, Seoul, 06110, Republic of Korea.",
            "firstname": "Kyoung Sun",
            "initials": "KS",
            "lastname": "Park"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 2020 Korea Institute of Oriental Medicine. Publishing services by Elsevier B.V.",
    "doi": "10.1016/j.imr.2020.02.002",
    "journal": "Integrative medicine research",
    "keywords": [
        "Dangguijagyag-san",
        "Dangguishaoyao-sanprimary dysmenorrhea",
        "Protocol",
        "Randomized controlled trial"
    ],
    "methods": null,
    "publication_date": "2020-04-18",
    "pubmed_id": "32300524\n16880317\n20074018\n16287008\n1416778\n10418884\n8917003\n16524531\n20091521\n19370576\n24417866\n27356390\n12230021\n18520045\n22178176\n26857875\n23303884\n24695505\n28654980\n21106059\n19454059\n7137249\n24280472\n40034\n22579432\n12903007\n24191165\n24266425\n15222022",
    "results": null,
    "title": "Efficacy and safety of herbal medicine (Dangguijagyag-san) for primary dysmenorrhea: study protocol for a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial.",
    "xml": "<Element 'PubmedArticle' at 0x7885039b6750>"
}