跳至主要内容
临床试验/CTRI/2025/04/085978
CTRI/2025/04/085978尚未招募2 期

A comparative study of Majoon Najah and Sharbat Ahmad Shahi in Depression-A randomized open label double arm clinical trial.

Ayurvedic and Unani Tibbia College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1.To evaluate safety and efficacy of proposed Unani formulations.

研究概览

简要总结

The study is Randomized, parallel group, open label,comparative clinical trial to evaluate the efficacy and safety of Majoon Najahand Sharbat Ahmed Shahi in the management of Depression. Depression is a commonillness characterized by persistent sadness and a loss of interest inactivities that one normally enjoys, accompanied by an inability to carry outdaily activities, for at least two weeks. It is a serious mental health concernthat impacts a person’s ability to work, their relationships, and significantlydestroys their quality of life. It is believed that severe depression can havedevastating consequences including suicidal ideation and attempts. About 3.8percent of the population suffers from depression, including 5 percent ofadults. Approximately 280 million people in the world have depression. Womenare 50 percent more likely to experience depression when compared to men with aprevalence rate of 6 percent among women and 4 percent in men. The NationalMental Health Survey 2015 in India reports that 1 in 20 individuals aged 18 orolder have suffered from depression at least once in their lifetime. More than700 000 people die by suicide every year. The World Health Organizationestimates that depression accounts for 4.3 percent of the global disease burdenand projects that it will become the leading contributor by 2030. In modernmedicine, first-line course of antidepressant treatment is insufficient toachieve remission in 68 percent of cases. The current antidepressants used havelimitations in both efficacy and tolerability. The scientists are increasinglyfocusing on exploring and developing new antidepressant drugs derived fromplants and their active compounds. Unani medicine is known for being safe,effective, readily accessible, cost effective and with least side effects.Certain plants have been utilized in the Unani system of medicine for treatingpsychiatric ailments including depression. The purpose of the study is toevaluate the efficacy and safety of Majoon Najah and Sharbat Ahmed Shahi in themanagement of Depression on modern scientific parameters.

研究设计

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

  • 1.Clinically diagnosed patients with Major Depressive Disorder.
  • 2.Patients with the score of more than or equal to 8 to less than or equal to 18 on Hamilton Depression Scale.
  • 3.Patients currently experiencing major depressive episode for more than or equal to 2 weeks.
  • 4.Patient currently not receiving any antidepressant or has discontinued more than 2 weeks prior to enrollment.
  • 5.Patient currently not on antidepressants or has discontinued 2 weeks prior to enrollment.

排除标准

  • 1.Severe cases of major depressive disorder with Hamilton Depression score of more than
  • 2.Patients below 18 and above 60 years of age.
  • 3.Pregnant and breastfeeding women.
  • 5.Patients with a history of bipolar depression, schizophrenia or other psychotic disorder.
  • 6.Initiating or stopping any formal psychotherapy within 6 weeks before enrollment.
  • 7.Patient taking any other antidepressant.
  • 8.Substance abuse history of psychoactive agents.
  • 9.Patients with suicidal ideation or behavior within past 3 months.
  • 10.Patients with Diabetes Mellitus, Hypertension, cardiovascular disorders, renal insufficiency, any other major chronic disorder and patients with any terminal condition such as cancer, AIDS etc.
  • 11.Patients who refuse written consent form for the study.

结局指标

主要结局

1.To evaluate safety and efficacy of proposed Unani formulations.

时间窗: 1.To evaluate efficacy: | Assessment of Hamilton Depression score on baseline, 15th, 30th, 45th,60th day. | 2.To evaluate safety: | Haemogram, LFT, KFT at baseline and 60th day.

2.To compare the results of two unani compound formulations in the management of Depression in respect to safety and efficacy.

时间窗: 1.To evaluate efficacy: | Assessment of Hamilton Depression score on baseline, 15th, 30th, 45th,60th day. | 2.To evaluate safety: | Haemogram, LFT, KFT at baseline and 60th day.

次要结局

  • Improvement in quality of life.(Assessment of Quality of life Index at baseline and after 60th day.)

研究者

发起方
Ayurvedic and Unani Tibbia College and Hospital
申办方类型
Government medical college

研究点 (1)

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