A RANDOMISED CONTROL CLINICAL TRIAL TO EVALUATE THE EFFICACY OF MAHAMASHA TAILA KARNAPOORNA AND MASHBALADI KWATHA ORALLY IN THE MANAGEMENT OF KARNANADA/TINNITUS
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Based upon the
研究概览
简要总结
This is a self financed clinical trial.So no recruitment is required .
I am Ph.D(SCHOLAR) In the field of ayurveda.I am conducting this trial to address a disease as well as a symptom called tinnitus.Ayurvedic interventions has many a times helped many times in cases of tinnitus.The drugs used here are in the form of eardrops as well as oral.Synergistic effect will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between age of 16-65 years irrespective of age, sex, caste, religion etc.
- •Patients will selected on the basis of classical signs and symptoms of Karnanada (Tinnitus).
- •Subjective type of tinnitus.
- •Patients willing to be registered for trial.
排除标准
- •1.Congenital deformity of external/middle ear 2.Blockage due to stenosis of external auditory canal/wax 3.Established diabetes mellitus and hypertension 4.Pregnant and lactating mothers.
- •5.Cases which required surgical intervention
- •Severe hearing loss and patients not fulfilling the inclusion criteria.
结局指标
主要结局
Based upon the
时间窗: During the study of 60 days (Trial Treatment duration ) examination of the patient will be done | on 0th, 7th ,30th day and 60th day. | After completing the study of 60 days patient will be reassessed on 75th and | 90th day. | Time period of study per patient – 90 days
score of THI the classification of severity of tinnitus will be done:
时间窗: During the study of 60 days (Trial Treatment duration ) examination of the patient will be done | on 0th, 7th ,30th day and 60th day. | After completing the study of 60 days patient will be reassessed on 75th and | 90th day. | Time period of study per patient – 90 days
THI SCORE BAND LEVEL OF TINNITUS
时间窗: During the study of 60 days (Trial Treatment duration ) examination of the patient will be done | on 0th, 7th ,30th day and 60th day. | After completing the study of 60 days patient will be reassessed on 75th and | 90th day. | Time period of study per patient – 90 days
次要结局
- A. To access the safety profile of both the drugs.(B. To access the compliance of both the drugs)
研究者
DR ASHU
SHRI KRISHNA AYUSH UNIVERSITY KURUKSHETRA HARYANA