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临床试验/CTRI/2024/03/063884
CTRI/2024/03/063884尚未招募2/3 期

Randomized Control Trials of Panchagavya Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression.

Dr Pramod Sakharam Mandalkar2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
114
试验地点
2
主要终点
To compare the effect of Panchagavya Ghrita Nasya and Hingwadi Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression.

研究概览

简要总结

Thepopulation-based study from India to report on depression shows that theprevalence of depression was 15.1%. India is home to an estimated 57 millionpeople (18% of the global estimate) affected by depression. Consideringthe huge burden and impact of depression and its importance as public healthconcern in developing and developed world, the World Health Organizationdeclared depression: Let’s Talk, as the theme of World Health day on April 07,2017 and lead a yearlong campaign on depression domains.There is also a need to study the course of depressive disordersin India so as to determine the need and duration of continuation treatment.The present study Randomized Control Trials will be carried out with aim to evaluate the efficacy of Panchagavya Ghrita Nasya in Vishada with special reference to Mildto Moderate Depression. For present study patients fulfilling the diagnosticcriteria of Mild to ModerateDepression(ICD-10), between the age group of 18 yrs to 50 yrs with irrespectiveof Gender, religions, socioeconomic status etc. Byusing Sample size formula; Sample size found 57, so that 57patients will be taken for study in each group. Total 114 numbers of patientswill be selected and randomly divided into two groups, named as Group-A (TrialGroup) and Group-B (Control Group) with Single Blind. Panchagavya Ghrita Nasya and HingwadiGhrita Nasya will be carried out in Group-A (Trial Group) patients andGroup-B (Control Group) patients respectively. Trial and Control Drugs will be purchase from GMC certifiedpharmacy. Both drugs will be administered through nasal routewith 3ml quantity in each nostril at morning hours continuous for 14 days. AllSOP of Nasya Karma will be strictly followed during and after treatment. All thefindings will be entered in Case Record Form (CRF) and for better understandingtabulation and graphical presentation will be done. Observations will be drawn on Before Treatment (0th day), During Treatment (At 7th day), AfterTreatment (At 14th day) and Weekly Follow-up after completion oftreatment (At 21th day). Result of study will be calculatedstatistically with appropriate statistical method. Resultwill be drawn on basis of Criteria of assessment and Statistical analysis.Discussion will be done on the basis of observations and result obtained duringthe treatment. Summary will be drawn and whole thesis work will be summarized.Conclusion will be draw strictly on basis of statistical Analysis and will beunbiased.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed as per the criteria for Mild and Moderate depression as per ICD-10, Indicated for Nasya Karma procedure, Patient is not allowed other medications for depression during study period.

排除标准

  • Patients below age 18 and above 50 years, Contraindicated for Nasya Karma, Patients with other psychiatric disorders and major depressive disorder, Patients with Chronic illness like Cancer, Hypertension, Diabetes Mellitus and Thyroid Disorders, Patients with suicidal tendency or thoughts and Organic Mood disorders, Chronic drug abuse, Chronic Alcoholic.

结局指标

主要结局

To compare the effect of Panchagavya Ghrita Nasya and Hingwadi Ghrita Nasya in Vishada with special reference to Mild to Moderate Depression.

时间窗: 21 days

次要结局

  • To review of Vishada according to Ayurved and Modern aspects.(To review of Nasya Karma according to Ayurved and Modern aspects.)

研究者

发起方
Dr Pramod Sakharam Mandalkar
申办方类型
Other []

研究点 (2)

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