CTRI/2024/07/070121招募中2 期
A Double-Blind, Randomized, Placebo-controlled Study to Assess the Efficacy of Rhuleave-K in subjects with Primary Dysmenorrhea and its associated symptoms. - NI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy female subjects 18 years or older
- •2. Subject has a history of regular menstrual cycles that typically occurs between every 28 ± 5 days with minimum 3 days of menstrual flow.
- •3. History of at least 4 consecutive painful periods in the past 6 month
- •4. WaLIDD score (Working ability, location, intensity, days of pain, dysmenorrhea score) above 5
- •5. Average menstrual pain score of 50 mm or above on VAS pain scale.
- •6. Willing for non-pregnant status during entire study period
- •7. Willing to provide the informed consent form
排除标准
- •1. Subject has a known allergy to any of the ingredients in any of the study medication products Subject has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure, or other condition that, in the Investigator’s judgment, contraindicates administration of the study medication
- •2. Subject has a current or history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent [defined as more than three per year]), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact subject safety and/or the study data
- •3. Subject has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge
- •4. Subject is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents).
- •5. Subject is pregnant, lactating, or less than 6 months postpartum
- •6. Subject is currently using an oral contraceptive for less than 3 months, has been on an unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months of the study
- •7. Subject has a history of alcohol intake daily or drug abuse.
- •8. Participant requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms
- •9. Participant does not agree to abstain from taking any analgesic and/or anti- inflammatory approximately 72 hours prior to the anticipated treatment period and throughout the dosing/assessment period. All pain and anti-inflammatory medications including supplements, topical heat or cold, and other products of topical application will be discontinued approximately 72 hours prior to the anticipated dosing for treatment period and throughout the dosing/assessment period
- •10. Subject with a medical disorder, condition, or history such that could impair the subject’s ability to participate or complete this study in the opinion of the investigator.
研究者
相似试验
进行中（未招募）
不适用
A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin (Pre- and Post Chemotherapy and Pre-Chemotherapy only) for Reduction in Severity of Oral Mucositis in Subjects with Multiple Myeloma (MM) Receiving High Dose Melphalan followed by Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)Oral Mucositis Induced by High Dose ChemotherapyCataract development associated with palifermin administrationMedDRA version: 8.1Level: LLTClassification code 10028130Term: Mucositis oralMedDRA version: 9.1Level: LLTClassification code 10007739Term: CataractEUCTR2006-003709-15-BEBiovitrum AB (publ)275
进行中（未招募）
不适用
A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin (Pre- and Post Chemotherapy and Pre-Chemotherapy only) for Reduction in Severity of Oral Mucositis in Subjects with Multiple Myeloma (MM) Receiving High Dose Melphalan followed by Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)Oral Mucositis Induced by High Dose ChemotherapyCataract development associated with palifermin administrationMedDRA version: 8.1Level: LLTClassification code 10028130Term: Mucositis oralMedDRA version: 9.1Level: LLTClassification code 10007739Term: CataractEUCTR2006-003709-15-DEBiovitrum AB (publ)275
进行中（未招募）
不适用
A study comparing two different dosing regimens of palifermin (beforeand after chemotherapy versus before chemotherapy) with placebo onthe effect of reducing oral mucositis in patients with multiple myelomawho have been given treatment with high dose melphalan followed bystem cell transplantation.Oral Mucositis Induced by High Dose ChemotherapyCataract development associated with palifermin administrationMedDRA version: 14.0Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 14.0Level: PTClassification code 10007739Term: CataractSystem Organ Class: 10015919 - Eye disordersEUCTR2006-003709-15-ATSwedish Orphan Biovitrum AB (publ)275
进行中（未招募）
不适用
A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin Pre- and Post Chemotherapy and Pre-Chemotherapy only for Reduction in Severity of Oral Mucositis in Subjects with Multiple Myeloma MM Receiving High Dose Melphalan followed by Autologous Peripheral Blood Stem Cell Transplantation PBSCT - EU PMC in Heme TxMieloma Multiple SubjectMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myelomaEUCTR2006-003709-15-ITAMGEN S.P.A.275
进行中（未招募）
不适用
A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin (Pre- and Post Chemotherapy and Pre-Chemotherapy only) for Reduction in Severity of Oral Mucositis in Subjects with Multiple Myeloma (MM) Receiving High Dose Melphalan followed by Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)Oral Mucositis Induced by High Dose ChemotherapyCataract development associated with palifermin administrationMedDRA version: 8.1Level: LLTClassification code 10028130Term: Mucositis oralMedDRA version: 9.1Level: LLTClassification code 10007739Term: CataractEUCTR2006-003709-15-HUBiovitrum AB (publ)