CTRI/2024/02/063175尚未招募4 期
An Open Label, Single Centre, Comparative, Randomized, ClinicalInvestigation Study to Evaluate the Efficacy, Safety, and Tolerability ofTrisamya PBM therapy in Mitigation and Treatment of Oral Mucositisduring Cancer Radiotherapy in Indian Patients with Head and Neck Cancer. - PBM Therapy
Trisamya Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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. Willing and able to understand and sign a written informed consent document prior to any study related procedures and ready to follow and in agreement to visits as per the study assessment visits.
- •2. Male or non-pregnant or non-lactating female Subjects between more than or equal to 18 to less than or equal to 65 years of age.
- •3. Histologically or cytologically confirmed, non-metastatic Head and Neck cancer, non- para nasal sinus (PNS), non-Nasopharynx who are receiving Radical or Adjuvant RT to the Oral cavity or Oropharynx with or without concurrent chemotherapy.
- •4. Adequate visual access for examination of the oral cavity viz- lips, buccal mucosa, floor of mouth, ventral and lateral tongue, soft and hard palate, Alveolus, and dorsal tongue.
- •5. ECOG performance status less than or equal to 2
- •6. Must consent to access, review, and analysis of previous medical and cancer history, including imaging data by the sponsor or a third party nominated by the sponsor.
- •7. Females of childbearing potential must have a negative urine pregnancy test at Screening and on Day -1 prior to enrollment.
- •8. Lactating females must agree to discontinue nursing before the study drug is administered.
- •9. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraceptive measures (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study.
排除标准
- •1. Reports a history of allergic response(s) to the active ingredient Turmeric or to any of the excipients of the product.
- •2. Reports history of allergic response(s) to phototherapy.
- •3. Presence of oral mucositis (WHO Score more than or equal to Grade 1) or other oral mucosal ulceration at study entry.
- •4. Current evidence of any active oral infection except oral candidiasis.
- •5. Subjects requiring parenteral or gastrointestinal tube-delivered nutrition for any reason.
- •6. Subjects with presence of symptoms associated with Oral Mucositis like burning sensation, difficulty in chewing, difficulty in drinking and difficulty in mouth opening at the time of enrolment.
- •7. Signs and Symptoms of active dental disease including toothache, severely mobile teeth, draining intraoral fistula, intraoral swelling (not associated with the primary tumor), gingival suppuration, gross caries or fractured teeth involving the pulp.
- •8. Presence of any oral lesions that may confound the ability to assess oral mucositis grade.
- •9. Known history or case of HIV or active hepatitis B or C (subjects who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
- •10. Any significant, uncontrolled medical diseases or conditions, as assessed by the Investigators that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, uncontrolled hypertension, NYHA II-IV congestive heart failure, myocardial infraction within 6 months of study, severe or uncontrolled chronic pulmonary disease, uncontrolled clinically relevant pulmonary edema or active uncontrolled infection).
- •11. Subjects with inadequate hepatic and renal function.
- •12. Any other significant medical condition of oral cavity including untreated active oral or dental infection, including severe tooth decay (caries).
- •13. Evidence of immediate life-threatening disease or a life expectancy of less than 3 months as per Investigator’s discretion.
- •14. Subjects who have participated in any investigational drug clinical study within one month of screening.
- •15. Refractory or terminally ill patients.
- •16. Any systemic disorder (including Sjogren syndrome) which have direct impact on the normal condition of oral cavity.
- •17. Pregnant and Lactating Female
- •18. Other conditions, which in the opinion of the investigator, makes the patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol.
研究者
相似试验
已完成
3 期
A Single Centre, Randomized, Open Label, Single Arm, Non-Comparative, Phase III Clinical study to Evaluate the Efficacy, Safety and Tolerability of JODOACT Cream in patients with acute musculoskeletal pain.CTRI/2023/05/052581PUNARJAN AYURVEDA PRIVATE LIMITED60
尚未招募
2 期
Clinical study on Guduchi Ghana Vati as a preventive remedy in pandemic of COVID-19CTRI/2020/05/025488ational Institute of Ayurveda
已完成
3 期
Effect Of Trumove Gel in reducing muscle and joint PaiCTRI/2023/05/052160Tirupati Pharma, India30
已完成
3 期
Effect Of Trumove Spray In reducing muscle and Joint PaiCTRI/2023/05/052521Tirupati Pharma, India30
进行中（未招募）
不适用
Continuation of cholic acid treatment for people with bile acid disorders who have previously taken part in clinical trials of cholic acid capsules.Patients with inborn errors of bile acid synthesis and metabolismMedDRA version: 14.0Level: PTClassification code 10070882Term: Inborn error in primary bile acid synthesisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-004528-36-Outside-EU/EEAAsklepion Pharmaceuticals, LLC30