Therapeutic evaluation of Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) in generalized anxiety disorder (GAD) associated insomnia.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Improvement in Insomnia Severity Score using Insomnia Severity Index (ISI) questionnaire.
研究概览
简要总结
Background: Sleeplessness is a sign of both anxiety and depression, and depression is the most prevalent of these mental illnesses. Patients presenting with comorbid insomnia and anxiety, treatment for insomnia may be the most efficient treatment strategy. Although benzodiazepines are commonly used for chronic insomnia and anxiety, but they can have serious side effects, such as drowsiness, addiction, falls, fractures and cognitive impairment etc. While on other hand Unani medicine has the potentials to treat insomnia and anxiety without any known adverse effects. Despite the strong correlation between insomnia and anxiety disorder, there is relative lack of integrative treatment approaches and protocols that address both insomnia and anxiety simultaneously. Therefore, we have selected two Unani drugs namely Tukhm-e- Khurfa siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) to assess their comparative efficacy in the treatment of insomnia and anxiety.
Objectives of the study:
Primary Objective: To evaluate the therapeutic efficacy and safety of Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) in Generalized Anxiety Disorder (GAD) associated insomnia.
Secondary Objective: To compare the therapeutic efficacy and safety of Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and Tukhm-e-Kahu (Lactuca sativa L.) in Generalized Anxiety Disorder (GAD) associated insomnia
Interventions:
Group A: 3 grams Tukhm-e-Khurfa Siyah (Portulaca oleracea L.) and
Group B: 3 grams Tukhm-e-Kahu (Lactuca sativa L.) per day in capsule form in two divided doses for 4 weeks.
Expected Outcome:
Improvement in sleep quality and quantity (Improvement in Insomnia Severity Index—ISI)
Improvement in GAD symptoms, (Reduction in GAD-7 Score)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients fulfilling Diagnostic Criteria of insomnia disorder and generalised anxiety disorder as per DSM 5-TR 2.Patients scoring 14+ on insomnia severity index (Clinical and Severe insomnia), and 3.Patients scoring upto 10 on GAD-7 scale (mild- moderate anxiety) 4.Mentally stable patients 5.Patient of all genders 6.Patients in age group of 18-65 years.
排除标准
- •1.Pregnant and lactating women 2.Previous history of known psychiatric disorders except generalised anxiety disorder 3.Night shift workers 4.Excessive consumption of beverages having caffeine (tea, coffee or cola >5 cups or glasses per day) 5.Any concomitant medication for insomnia or anxiety 6.Patients having past history of seizures or epilepsy 7.Terminally ill, having any malignancy or chronic progressive medical or surgical condition 8.Patients having uncontrolled diabetes mellitus or hypertension 9.Patients of hyperthyroidism 10.Patients suffering from itching conditions like scabies, eczema and psoriasis.
结局指标
主要结局
1.Improvement in Insomnia Severity Score using Insomnia Severity Index (ISI) questionnaire.
时间窗: Baseline, | 4 weeks
2. Improvement in Generalised anxiety disorder score using GAD-7 questionnaire.
时间窗: Baseline, | 4 weeks
次要结局
- improvement in clinical symptoms(1. mood uplifting)
研究者
SAMREEN SAYYED
Jamia Hamdard University