Evaluation of Efficacy and Safety of Inkibab i Shabat (Steaming of Anethum graveolens) and Habbe Gule Aak in the Management of Fibromyalgia An Open Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 1.VAS (visual analogue scale)
研究概览
简要总结
Fibromyalgia (FM) is a syndrome characterized by chronic widespread musculoskeletal pain at multiple tender points. It is characterized by joints stiffness, systemic symptoms like mood disorders, fatigue, anxiety, cognitive dysfunction (Fibro Fogg) and insomnia. The prevalence of FM is about 1-2%.It is highly female dominant disease accounting for 80–96%.FM generally appears in between 30-35 years. A subjective feeling of swelling without objective oedema, paresthesia, cognitive disorders, dizziness and weakness are also frequent symptom of the disease. The exact cause and pathophysiology of FM is still unknown, several factors like, dysfunction of central and autonomic nervous system, neurotransmitters, genetic predisposition, environmental exposure, hormonal factor and psychiatric aspect have been implicated in triggering FM.
In Unani classical literature, no disease is mentioned as Fibromyalgia, however its common symptoms such as Body ache, Restlessness, Mood disorder, Sleep disturbance and gut disturbance etc. and their treatments have been elaborated. So, FM is considered as Marz e Ghair Mudawwan (disease not mentioned in Unani literature). In such diseases which are not mentioned in the original text treatment is chosen on the basis of sign and symptoms. Unani system of medicine consists of three types of treatment methods; Ilaj bil Tadbir wal Taghziya (Regimenal and Dieto-therapy), Ilaj bil Dawa (Pharmacotherapy) and Ilaj bil Yad’(Surgery). Ilaj bil Tadbir includes several nonpharmacological or least pharmacological modalities, one of which is Inkebab. Anethum graveolens used as Inkebab is useful in the treatment of musculoskeletal problems. It is a therapeutic herb, grown all over the world, Its extract has analgesic,anti-inflammatory and smooth muscle relaxant action. Habbe Gule Aak (Unani polyherbal pill) is useful in treating musculoskeletal diseases and chronic pain because of its anti-inflammatory and analgesic action. and Control group is subjected to Myofascial Release (MFR).
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
入选标准
- •Age group between 18 to 60,All Genders, Chronic pain complaint above 3 months ,Patient of fibromyalgia having no surgical indication, Patient having no malignancy, VAS pain score more than or equal to 6 in the two previous weeks, formal consent to study participation, Able to speak, read and understand english or hindi, Patient fulfilling the inclusion criteria and agree to follow the protocol.
排除标准
- •Patient with current diagnosis of infection or musculoskeletal inflammatory conditions, Use of NSAIDs ,opioids, anti depressants, betablockers in the 7 days before enrollment ,Chronic or acute pulmonary hematologic and kidney diseases, patient with confirm diagnosis of adrenal dysfunction , anemia, bone marrow disease, chronic fatigue syndrome, functional disorders, thyroid disorders, hypertension, diabetes mellitus, Lyme disease, multiple sclerosis, rheumatoid autoimmune disorders, spinal facet pain, vitamin and mineral deficiency, Patients with Active malignancy, Participation to other experimental studies in the month prior to the enrollment, Patients with Severe heart conditions or pacemaker, Chronic abuse of illicit drug and alcohol, Patients with Active Neuropsychiatric disorders, Females on oral contraceptive pills, Females in Menopausal Transition, Patient with permanent deformity, Patient having muscular contracture, Physiological state as pregnancy and lactation, Patients with history of trauma, Unwillingness or inability to comply the requirement of the protocol.
结局指标
主要结局
1.VAS (visual analogue scale)
时间窗: On day 0,7,14,21,28 and 35
2.WPI (widespread pain index)
时间窗: On day 0,7,14,21,28 and 35
3.SSI (symptoms severity) index)
时间窗: On day 0,7,14,21,28 and 35
4.FIQR (revised fibromyalgia impacted questionnaire)
时间窗: On day 0,7,14,21,28 and 35
次要结局
- SF12(Quality of life)(On day 0,7,14,21,28 and 35)
研究者
Tazeen Naved
Hakim Syed Ziaul Hasan Government Unani Medical and Hospital
