Conceptual and Applied Study of Shadvidha Avekshya Kaala wsr to Madhyebhukta Aushadha Kaala
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Establishment of role and importance of Shadvidha Avekshya Kaala in therapeutics in terms of better efficacy of the treatment prescribed.
研究概览
简要总结
Introduction: In Ayurveda, more emphasis has been given to Kaala with regards to drug administration. According to Acharya Charaka, Kaala is the factor which determines the manifestation of desired effects of the administered drug therapy.
Significance: To fulfil the objectives like multidimensional usage and quick action of medicines and also to enhance the potency of Ayurveda treatment modality, administration of drugs with regards to Dina (different parts of the day), Atura (nature of the patient), Aushadha (nirannaadi aushadha kaala), Vyadhi (nature/stage of the disease), Jirna-linga (stage of the digestion of food) and Ritu (nature of the season) is of utmost importance.
Materials and Methods: The study will be carried out in two phases- Conceptual study and Clinical study. Clinical study will be started after obtaining clearance from Institutional Ethics Committee. Clinical study: Patients suffering from Vidagdhajirna will be divided into two groups by using computer generated randomization chart. Abhayaadi Gutikaa will be used as a drug and its efficacy given in two different Aushadha Kaalas will be evaluated.
Group 1 will receive the drug at madhyebhukta kaala (in the middle of the meal, twice a day) while Group 2 will receive it at niranna kaala (empty stomach, twice a day).
Results and Discussion: Data generated during the above study will be presented in a systemic manner and shall be analyzed statistically.
Follow up: After completion of therapy, follow up will be done for 14 days to assess the status of patients. Adverse effects: This proposal will be reviewed and approved by Institutional Ethics Committee, I.T.R.A., Jamnagar which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group between 18 to 60 years.
- •Patients having classical signs and symptoms of Vidagdhajirna (minimum 3 symptoms).
- •Patients having chronicity not more than one month.
排除标准
- •Patients having age less than 18 years and more than 60 years.
- •Patients suffering from any systemic disease which intervenes with the treatment.
- •Patients having chronicity more than one month.
- •Patients in which one or more contents of Abhayaadi Gutikaa are contraindicated.
- •Pregnant and lactating women.
结局指标
主要结局
Establishment of role and importance of Shadvidha Avekshya Kaala in therapeutics in terms of better efficacy of the treatment prescribed.
时间窗: 4 weeks
次要结局
- To improve quality of life(28 days)