A Cross over, Double blinded, Interventional study to evaluate the skin sensitivity, safety and tolerability of two types of Amrutanjan Pain Balm in healthy subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The following parameters will be assessed for each subject;
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 12 healthy adult subjects will be divided into 2 arms with 6 in each. Six Subjects will be topically applying the pain balm of product A and six subjects will be topically applying Product B over forehead region and they will be in house for a period of 8 hours and monitored at 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs for clinical scores of erythema/dryness/wrinkles/oedema. Then a wash out period of 5 days is given. Patients with any erythema/ oedema will not be included for the Subsequent study procedure. Then, the subjects will be crossed over and the same procedures will be repeated. The following parameters will be assessed for each subject; Erythema/dryness/wrinkles Oedema Mean Irritation Index
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex aged above 18 years.
- •2.Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
排除标准
- •1.Past history of allergy, asthma and atopy.
- •2.Known allergy to compounds of investigational product.
- •3.Participation in an investigational drug trial in the 30 days prior to the screening visit.
- •4.Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
- •5.Subjects with known history of Sinusitis, Migraine.
结局指标
主要结局
The following parameters will be assessed for each subject;
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
3. Mean Irritation Index
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
Scale: Reaction
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
1. Erythema/dryness/wrinkles
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
2. Oedema
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
1- Very slight erythema/dryness withshiny appearance/very slight oedema
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
2 - Slight erythema/dryness/wrinkles/slight oedema
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
Clinical score for Erythema/ Dryness/Wrinkles/oedema : scale 0-4
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
0- No reaction
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
3 - Moderate erythema/dryness/wrinkles/moderate oedema
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
4 - Severe erythema/wrinkles/scales/severe oedema
时间窗: Time Frame: Baseline (0 minute), 5 min., 15 min., 30 min., 1 hr, 2 hr, 4 hr, 6 hr and 8 hrs.
次要结局
- Time to onset of skin irritation/burning sensation Time frame: 0-8 hrs post dose(Time taken for complete relief of skin irritation/burning sensation.)