Indigo ( DrugBank: Indigo )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 97 | 潰瘍性大腸炎 | 7 |
| 289 | クロンカイト・カナダ症候群 | 1 |
| 300 | IgG4関連疾患 | 7 |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR2000037220 | 2020-10-01 | 2020-08-27 | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Traditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Recruiting | Both | Traditional Chinese medicine group:40;Western medicine group:40; | China | |||
| 2 | ITMCTR2000003772 | 2020-10-01 | 2020-08-27 | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis | ulcerative colitis | Traditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules; | Shuguang Hospital affiliated to Shanghai University of traditional Chinese Medicine | NULL | Recruiting | Both | Traditional Chinese medicine group:40;Western medicine group:40; | China | |||
| 3 | JPRN-jRCTs031190156 | 09/12/2019 | 09/12/2019 | IN for practical use | Study on efficacy and safety of indigo naturalis in patients with intractable ulcerative colitis. | ulcertive colitis | administration of one indigo naturalis FC enteric-coated tablet (including 0.5g indigo naturalis per tablet)twice a day for 4 weeks | Kanai Takanori | NULL | Recruiting | >= 16age old | Not applicable | Both | 100 | Phase 3 | Japan |
| 4 | JPRN-UMIN000029633 | 2017/12/27 | 20/10/2017 | The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis. | The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis. - The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis. | ulcerative colitis | administration of the suppository ,which contains 0.05g indigo naturalis, for 4 weeks | Keio University School of Medicine | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 5 | JPRN-jRCTs071180073 | 08/08/2017 | 22/03/2019 | Further maintenance of remission for a year after Qing-Dai withdrawal in ulcerative colitis treatment:randomized controlled trial | Further maintenance of remission for a year after Qing-Dai withdrawal in ulcerative colitis treatment:randomized controlled trial - None | Ulcerative colitis Ulcerative colitis | arm A :stop oral administration of indigo naturalis arm B :continue oral administration of indigo naturalis | Kitazono Takanari | NULL | Complete | >= 16age old | Not applicable | Both | 40 | Phase 2 | Japan |
| 6 | JPRN-UMIN000021460 | 2015/10/20 | 13/03/2016 | Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. | Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. - Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture | patients with ulcerative colitis had high risk of colitic cancer.A:patients suspected dysplasia(low/high grade) or cancer.B:patients had plan of treatment of the dysplasia or cancer. | 40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded. | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 30 | Not selected | Japan |
| 7 | JPRN-UMIN000017359 | 2015/05/07 | 01/05/2015 | Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis | Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis - Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis | ulcerative colitis | Oral administration of Indigo naturalis 2g/day, 4 weeks | Osaka University, Graduate School of Medicine, Department of Gastroenterology and Hepatology | NULL | Recruiting | 20years-old | 95years-old | Male and Female | 20 | Not selected | Japan |
289. クロンカイト・カナダ症候群
臨床試験数 : 1 / 薬物数 : 1 - (DrugBank : 1) / 標的遺伝子数 : 0 - 標的パスウェイ数 : 0
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000025246 | 2016/12/13 | 13/12/2016 | Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome. | Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome. - Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome. | chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome | indigo naturalis 2g/day for oral administration is be administered daily in 2 divided doses during 8weeks. | Keio University Gastroenterology and Hepatology | NULL | Complete: follow-up complete | 20years-old | 69years-old | Male and Female | 6 | Not selected | Japan |
300. IgG4関連疾患
臨床試験数 : 40 / 薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05662241 (ClinicalTrials.gov) | September 30, 2022 | 14/12/2022 | A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With IgG4-Related Disease (INDIGO) | IgG4 Related Disease | Drug: Obexelimab;Other: Placebo | Zenas BioPharma (USA), LLC | NULL | Recruiting | 18 Years | N/A | All | 200 | Phase 3 | United States |
| 2 | JPRN-jRCTs051210171 | 07/02/2022 | 07/02/2022 | The treatment using indigo naturalis for autoimmune pancreatitis | Safety of indigo naturalis in patients with autoimmune pancreatitis - Indigo naturalis for autoimmune pancreatitis | Autoimmune pancreatitis Autoimmune pancreatitis | Administration of indigo naturalis | Kamata Ken | NULL | Recruiting | >= 20age old | Not applicable | Both | 10 | Phase 2 | Japan |
| 3 | EUCTR2017-002214-31-NL (EUCTR) | 23/07/2019 | 09/08/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2017-002214-31-IT (EUCTR) | 26/02/2019 | 04/11/2020 | Study to Evaluate the Safety and Effectiveness of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) - INDIGO | IgG4-Related Disease MedDRA version: 21.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NA Product Code: [XmAb5871] | Xencor INC | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden | ||
| 5 | EUCTR2017-002214-31-BE (EUCTR) | 22/10/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden | |||
| 6 | EUCTR2017-002214-31-GB (EUCTR) | 03/08/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden;United States;Spain;Israel;United Kingdom | |||
| 7 | EUCTR2017-002214-31-SE (EUCTR) | 17/10/2018 | Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) | IgG4-Related Disease MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: XmAb5871 INN or Proposed INN: XmAb5871 Other descriptive name: XMAB5871 | Xencor, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden |