A Clinical Study on Migraine without Aura (Shaqeeqa) and its Management with Polyherbal Formulation- A Randomized Standard Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.To assess the safety and efficacy of the proposed Unani Polyherbal Formulation on scientific parameters.
研究概览
简要总结
This study is a randomised, parallel group, active control clinical trial to evaluate the efficacy and safety of the aqueous extract of Unani polyherbal formulation in the management of Migraine without aura and to Compare it’s efficacy with a standard drug.
Migraine headaches can be so severe that it can interfere with person’s daily activities and is associated with a wide range of comorbidities, which range from stress and sleep disturbances to anxiety, depression and even suicide.
Migraine worsens the quality of life of individuals and place a significant burden on society.
Moreover, the conventional medical treatment of migraine is linked to large number of side effects, which cause dependance and drug withdrawal symptoms.
In contrast to this, a large number of single herbs, compound drugs and regimenal therapies in Unani System of Medicine have been found to be effective in the management of migraine related symptoms without observation of significant side effects and are in clinical practice from many centuries. However, the safety and efficacy of these drugs have not been evaluated
on scientific parameters. Hence, there is a need to develop a safe, efficacious and economical drug on modern scientific parameters from the herbal treasury of Unani medicine for the treatment of Migraine.
The purpose of this study is to provide a safe and effective drug for managing migraine and to compare its efficacy with a standard drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
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.Patient willing to participate in the study and sign the informed consent form.
- •2.Patients between the age of 18 and 65 years of either sex.
- •3.Diagnosed cases of migraine based on ICHD-3 criteria.
排除标准
- •1.Patients of psychotic and neurotic disorder.
- •2.Patients taking Anti-migraine, Anti-epileptic, Anti- Psychotic, Anti-Depressant, Sedative and Hypnotic medications.
- •3.Patients with refractive errors.
- •4.Patients suffering from eye disease, otitis media, sinusitis, pharyngitis, gingivitis,rhinitis, and tonsillitis.
- •5.Pregnant and lactating women.
- •6.Renal & hepatic insufficiency and malignancy.
- •7.Diagnosed cases of Malignant Hypertension and Diabetes mellitus.
- •8.Patients with Bradycardia or Hypotension.
- •9.Diagnosed cases of obstructive pulmonary disease like COPD or Asthma.
- •10.Patients with neck muscle and cranial bones pain.
结局指标
主要结局
1.To assess the safety and efficacy of the proposed Unani Polyherbal Formulation on scientific parameters.
时间窗: 1.To evaluate efficacy: | a. Assessment of subjective parameters at base line, 10th, 20th, 30th, and 42nd Day. | b. Assessment of Migraine disability at baseline and after 6 weeks. | 2.To evaluate safety: | Haemogram, LFT, KFT at base line, 10th day and after 6 weeks.
2.To compare the results of Polyherbal Unani Formulation with the standard control in the treatment of Migraine in respect of safety and efficacy.
时间窗: 1.To evaluate efficacy: | a. Assessment of subjective parameters at base line, 10th, 20th, 30th, and 42nd Day. | b. Assessment of Migraine disability at baseline and after 6 weeks. | 2.To evaluate safety: | Haemogram, LFT, KFT at base line, 10th day and after 6 weeks.
次要结局
- To evaluate the effect of Unani Polyherbal Formulation on quality of life of the patient (QOL).(Assessment of Quality of life of patient at baseline and after 6 weeks.)
研究者
Shaziya Siddiqui Niyaz Ahmed
Ayurvedic and Unani Tibbia College and Hospital