THERAPUTIC EVALUATION OF TULSHI JIWAN PLUS OIL FOR PAIN RELIEF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CHANGE IN PATIENT’S GLOBAL ASSESSMENT OF THE CHRONIC PAIN ACTIVITY SCALE
研究概览
简要总结
THE INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL IS THE MEDICAL SCHOOL OF THE SIKSHA O ANUSANDHAN UNIVERSITY SITUATED IN BHUBANESWAR, ODISHA, INDIA.
AIMED-
-
TO ASSESS THE SYNERGESTIC EFFECT OF ALL THESE COMBINED INGREDIENTS.
-
TO GENERATING EVIDENCE FOR THE SCIENTIFIC VALIDATION OF THE CLINICAL EFFICACY AND SAFETY OF THESE HERBAL FORMULATION.
TULSHI JIVAN PLUS IS A POLYHERBAL AYURVEDIC FORMULATION CONTAINING MUSTARD OIL (Brassicaceae juncea)*,*TARPIN OIL (*Pinus bhutanica),*LAHASUMN (*Allium sativam),*RATAN JOT (*Onosma echioides),*PUDINA SATWA (*Mentha sylrestris),*AJWAN SATWA (Trachyspermum ammi)ANDKAPOOR (Camphora officinoroum).
ALL OF THESE INGREDIENTS HAVE ALREADY PROVED ITS EFFICACY IN THE MANAGEMENT OF PAIN IN AYURVEDIC SCIENCE.
THE PRESENT STUDY ENTITLED “THERAPUTIC EVALUATION OF TULSHI JIWAN PLUS OIL FOR PAIN RELIEFâ€.
THIS INITIATIVE IS BASICALLY A SUPPLEMENT TO THE SIMILAR VENTURE BEING WORKED OUT AS AN ACTIVITY UNDER THE AYURVEDA CLINICAL TRIALS (A.C.T.) PROJECT OF THE AYURVEDIC PHARMACOPOEIA COMMITTEE (APC).
THIS PROGRAMME IS EXPECTED TO SCIENTIFICALLY SUBSTANTIATE THE CLAIMS REGARDING CLINICAL EFFICACY AND SAFETY OF THESE CLASSICAL AYURVEDIC FORMULATIONS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •EITHER SEX AGED BETWEEN 30 TO 65 YEARS PATIENTS WITH PRIMARY BACK, KNEE AND ANY MUSCULAR PAIN WILLING AND ABLE TO PARTICIPATE IN THE STUDY.
排除标准
- •1.HISTORY OF ANY TRAUMA/ FRACTURED JOINT / SURGICAL/DIAGNOSTIC INTERVENTION WITH REFERENCE TO THE AFFECTED JOINT(S).
- •2.GROSS DISABILITY IN PERFORMING DAILY NORMAL ROUTINE I.E. BED RIDDEN PATIENTS OR CONFINED TO A WHEELCHAIR.
- •3.PATIENTS WITH CO MORBIDITIES SUCH AS GOUTY ARTHRITIS, RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS.
- •4.PATIENTS HAVING ANY DEFORMITY OF KNEE HIP OR BACK ALTERING THE GAIT AND POSTURE OF THE PATIENT.
- •5.PATIENTS WITH UNCONTROLLED HYPERTENSION (>160/100 MM OF HG).
- •6.PATIENTS WITH UNCONTROLLED DIABETES MELLITUS{HBA1C>9%} 7.PATIENTS WITH EVIDENCE OF MALIGNANCY.
- •8.PATIENTS ON PROLONGED (> 6 WEEKS) MEDICATION WITH CORTICOSTEROIDS, ANTIDEPRESSANTS, ANTICHOLINERGICS, ETC.
- •OR ANY OTHER DRUGS THAT MAY HAVE AN INFLUENCE ON THE OUTCOME OF THE STUDY.
- •9.PATIENTS WHO HAVE A PAST HISTORY OF ATRIAL FIBRILLATION, ACUTE CORONARY SYNDROME, MYOCARDIAL INFARCTION, STROKE OR SEVERE ARRHYTHMIA IN THE LAST 6 MONTHS.
- •11.PREGNANT / LACTATING WOMAN.
- •12.PATIENTS WHO ARE CURRENTLY PARTICIPATING IN ANY OTHER CLINICAL TRIAL.
- •13.ANY OTHER CONDITION WHICH THE PRINCIPAL INVESTIGATOR THINKS MAY JEOPARDIZE THE STUDY.
结局指标
主要结局
CHANGE IN PATIENT’S GLOBAL ASSESSMENT OF THE CHRONIC PAIN ACTIVITY SCALE
时间窗: AT BASELINE, 7TH DAY, 14TH DAY, 21ST DAY, 28TH DAY AND AT THE END OF FOLLOW UP AFTER 06 WEEKS
次要结局
- SAFETY AND EFFICACY OF THE DRUG IN THE PATIENT WITH CHRONIC PAIN(AT BASELINE, 7TH DAY, 14TH DAY, 21ST DAY, 28TH DAY AND AT THE END OF FOLLOW UP AFTER 06 WEEKS)