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临床试验/CTRI/2026/04/109578
CTRI/2026/04/109578尚未招募不适用

A prospective multicentre real world study to assess the effectiveness and safety of Oral Nutritional Supplement (ONS) containing Cissus Quadrangularis (CQ) in fracture healing in adults with fractures, in India

Indchemie Health Specialties Pvt Ltd2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
2

研究概览

简要总结

This study will use a prospective observational real world study recruiting people with fractures who come for routine care at the study sites and who are treated with Cissus Quadrangularis. They will be recruited for this study after completion of the informed consent process. The recruitment period is for two months. The study is planned as a follow up with a period of four months patient tracking period after recruitment. The primary objective is to evaluate the effectiveness of oral nutritional supplement containing Cissus Quadrangularis in fracture healing as assessed by radiological assessment, pain, swelling and sleep disturbances.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Suffered a fracture- Simple fracture/ Open fractures/ Comminuted fracture Administered CQ for management of fracture (only/in combination with other medication) Provide consent to participate.

排除标准

  • Do not provide consent Patients with hypercalcemia, Paget disease, malignant tumors, joint dysfunction, and significant polytrauma.
  • Patients on steroid therapy or immunosuppressants and any other medications affecting bone metabolism.
  • Pregnant or lactating patients.

研究者

发起方
Indchemie Health Specialties Pvt Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Rajeev Raman

Joint & Bone Care Hospital

研究点 (2)

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AI-Based Medical Image Analysis Software using X-ray Imaging.Other early complications of trauma, (2) ICD-10 Condition: S920||Fracture of calcaneus, (3) ICD-10 Condition: S921||Fracture of talus, (4) ICD-10 Condition: S923||Fracture of metatarsal bone(s), (5) ICD-10 Condition: S924||Fracture of great toe, (6) ICD-10 Condition: S925||Fracture of lesser toe(s), (7) ICD-10 Condition: S928||Other fracture of foot, except ankle, (8) ICD-10 Condition: S820||Fracture of patella, (9) ICD-10 Condition: S821||Fracture of upper end of tibia, (10) ICD-10 Condition: S822||Fracture of shaft of tibia, (11) ICD-10 Condition: S823||Fracture of lower end of tibia, (12) ICD-10 Condition: S824||Fracture of shaft of fibula, (13) ICD-10 Condition: S825||Fracture of medial malleolus, (14) ICD-10 Condition: S826||Fracture of lateral malleolus, (15) ICD-10 Condition: S828||Other fractures of lower leg, (16) ICD-10 Condition: S720||Fracture of head and neck of femur, (17) ICD-10 Condition: S721||Pertrochanteric fracture, (18) ICD-10 Condition: S722||Subtrochanteric fracture of femur, (19) ICD-10 Condition: S723||Fracture of shaft of femur, (20) ICD-10 Condition: S724||Fracture of lower end of femur, (21) ICD-10 Condition: S728||Other fracture of femur, (22) ICD-10 Condition: S620||Fracture of navicular [scaphoid] bone of wrist, (23) ICD-10 Condition: S621||Fracture of other and unspecifiedcarpal bone(s), (24) ICD-10 Condition: S622||Fracture of first metacarpal bone, (25) ICD-10 Condition: S623||Fracture of other and unspecifiedmetacarpal bone, (26) ICD-10 Condition: S625||Fracture of thumb, (27) ICD-10 Condition: S626||Fracture of other and unspecifiedfinger(s), (28) ICD-10 Condition: S520||Fracture of upper end of ulna, (29) ICD-10 Condition: S521||Fracture of upper end of radius, (30) ICD-10 Condition: S522||Fracture of shaft of ulna, (31) ICD-10 Condition: S523||Fracture of shaft of radius, (32) ICD-10 Condition: S525||Fracture of lower end of radius, (33) ICD-10 Condition: S526||Fracture of lower end of ulna, (34) ICD-10 Condition: S420||Fracture of clavicle, (35) ICD-10 Condition: S421||Fracture of scapula, (36) ICD-10 Condition: S422||Fracture of upper end of humerus, (37) ICD-10 Condition: S422||Fracture of upper end of humerus, (38) ICD-10 Condition: S423||Fracture of shaft of humerus, (39) ICD-10 Condition: S424||Fracture of lower end of humerus, (40) ICD-10 Condition: S429||Fracture of shoulder girdle, partunspecified, (41) ICD-10 Condition: S490||Physeal fracture of upper end of humerus, (42) ICD-10 Condition: S491||Physeal fracture of lower end of humerus, (43) ICD-10 Condition: S498||Other specified injuries of shoulder and upper arm, (44) ICD-10 Condition: S590||Physeal fracture of lower end of ulna, (45) ICD-10 Condition: S591||Physeal fracture of upper end of radius, (46) ICD-10 Condition: S592||Physeal fracture of lower end of radius, (47) ICD-10 Condition: S598||Other specified injuries of elbowand forearm, (48) ICD-10 Condition: S698||Other specified 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A study to evaluate whether a nutritional supplement... | 临床试验