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临床试验/CTRI/2024/09/073644
CTRI/2024/09/073644尚未招募4 期

To study the efficacy of sesame oil shiroabhyanga and intake of buffalo milk in the management of nidranash.

Prachi Sudhir Bute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
1. To study the effect of sesame oil Shiroabhyanga and intake of buffalo milk in the management of Nidranash.

研究概览

简要总结

Topic:- TO STUDY THE EFFICACY OF SESAME OIL SHIROABHYANGA AND INTAKE OF BUFFALO MILK IN THE MANAGEMENT OF NIDRANASH. Aim:- To study the effect of sesame oil Shiroabhyanga and intake of buffalo milk in the management of Nidranash. Objective:-

Primary Objective:- To study the effect of sesame oil Shiroabhyanga and intake of buffalo milk in the management of Nidranash. Secondary Objectives:- 1. To study the conceptual aspects of Nidranash. 2. To study the properties of sesame oil and buffalo milk. Methodology:- Study design Screening of the subjects from population will be done on the basis of inclusive criteria and exclusive criteria. Selection of the subjects will be done by using lottery method.

Individuals will be given sesame oil Shiroabhyanga in the morning and 150 mL of buffalo milk after the meal before going to bed. Follow up at D-10 and after study D-60. Then assessment will be done by objective and subjective parameters before and after the study and subjective parameters on D-0, D-10, D-20, D-30, D-40, D-50, D-60.

Statistical analysis with appropriate test and interpretation will be done. Study Population:-  On the basis of clinical examination and history, total individuals will be selected according to their eligibility criteria. Individuals will be given sesame oil Shirobhyanga in the morning and 150mL of buffalo milk after the meal before going to bed.  Inclusion criteria:- 1. Age group 30-50 years. 2. Irrespective of sex, education, religion, and socio-economical status. 3. Subjects with classical signs and symptoms of Nidranash like Nidraalpata, Bhram, Tandra, Khanditnidra, etc. 4. Individual willing for regular follow up. 5. Individual having disturbed sleep with mild hypertension, mild depression and generalised anxiety disorder and without any complications of other diseases. Exclusion criteria:- 1. Individual with age group below 30 years and above 50 years of age. 2. Subject having any systemic diseases. 3. Contraindicated for Shiroabhyanga. 4. Patient having chronic diseases. 5. Patients with alcohol addiction, drug abuser, accidental cases and post operative cases. Withdrawal criteria:- 1. Subject who develop any unwanted symptoms during the study. 2. Subjects who are unable to give follow up.

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
30.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Age group 30-50 years.
  • Irrespective of sex, education, religion and socio-economical status.
  • Individual willing for regular follow up.
  • Individual with classical signs and symptoms of Nidranash like Nidraalpata, Bhram, Tandra, Khanditnidra, etc.
  • Individual having disturbed sleep, mild hypertension, mild depression and generalised anxiety disorder and without any complications of other diseases.

排除标准

  • Subjects with age group below 30 years and above 50 years of age of both sexes.
  • Subjects having any systematic disease.
  • Contraindicated to Shiroabhyanga.
  • Old age and old age related diseases.
  • Patient not ready to give informed consent.
  • Patient with chronic diseases.
  • Patients with alcohol addiction, drug abused, accidental cases and post operative cases.

结局指标

主要结局

1. To study the effect of sesame oil Shiroabhyanga and intake of buffalo milk in the management of Nidranash.

时间窗: 18 months.

2. To study the effect of sesame oil shiroabhyana in nidranash.

时间窗: 18 months.

3. To study concept of insomnia.

时间窗: 18 months.

4. To study the effect of intake of buffalo milk in nidranash.

时间窗: 18 months.

5. To study the combined effect of sesame oil shiroabhyanaga and intake of buffalo milk in nidranash.

时间窗: 18 months.

次要结局

  • 1. To study the conceptual aspects of Nidranash.(2. To study the properties of sesame oil & buffalo milk. 3. To study the conceptual aspects of insomnia.)

研究者

发起方
Prachi Sudhir Bute
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Prachi Sudhir Bute

Vidarbha Ayurved Mahavidyalaya Amravati

研究点 (1)

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