Comparative Clinical Validation study of Unani Pharmacopoeial formulation Habb-e-Ikhtilaj vs Majoon-e Najah in Malankhuliya (Mixed Anxiety Depressive Disorder)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Improvement in the signs and symptoms of Malankhuliya (Mixed Anxiety Depressive Disorder). Which will be assessed on the basis of Hamilton’s Anxiety rating scale and Hamilton’s Depression rating scale.
研究概览
简要总结
This study is designed as a Multi centric, Randomized, Parallel Group, Active Controlled trial in patients with Malankhuliya (Mixed Anxiety Depressive Disorder) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every two weeks (i.e., 0, 2nd, 4th and 6th week). The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 6 weeks (42 days). Laboratory parameters for safety assessment will be conducted at baseline, first follow-up and on completion of the protocol therapy (i.e., at 0, 2nd and 6th week).
Composition ofHabb-e-Ikhtilaj:
| **S. | |||
| No.** |
Unani Name
Botanical Name
Weight
|1
Turbud
Operculina turpethum L.
5 g
|2
Aftimoon
Cuscuta reflexa Roxb.
2 g
|3
Usara-e-Ghafis
Gentiana Olivieri Griseb.
500 mg
|4
Usara-e-Afsanteen
Artemisia absinthium, Linn
500 mg
|5
Shaham-e-Hanzal
Citrullus colocynthis
500 mg
|6
Muqil
Commiphora mukul
500 mg
|7
Anisoon
Pimpinella anisum L.
500 mg
|8
Mastagi
Pistacia lentiscus Linn
500 mg
|9
Aab
-
Q.S.
Composition ofMajoon-e-Najah:
| S. No. |
Unani Name
Botanical Name
Weight
|1
Post-e-Halela Kabli
Terminalia chebula Retz.
50 g
|2
Post-e-Balela
Terminalia belerica Roxb
50 g
|3
Aamla
Emblica officinalis Gaertn.
50 g
|4
Halela Siyah
Terminalia chebula Retz.
50 g
|5
Turbud
Operculina turpethum (L) Silva Manso
25 g
|6
Bisfayej
Polypodium vulgare L.
25 g
|7
Aftimoon
Cuscuta reflexa L.
25 g
|8
Ustukhuddus
Lavandula stoechas L.
25 g
|9
Asl or Qand Safed
Apis mellifera L.
600 g
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically significant distress or impairment in social, occupational or other important areas of functioning.
- •2.Patients falling in the category of mild to moderate anxiety and depression-according to Hamilton rating scale.
- •Patients fulfilling the diagnostic criteria laid down by DSM-IV for MADD i.e. Patients with persistent or recurrent dysphoric mood lasting at least one month companied by four or more following symptoms for at least one month: i.
- •Fatigue or low energy ii.
- •Low self-esteem or feeling of worthlessness iii.
- •Difficulty concentrating or mind going blank iv.
- •Sleep disturbance (difficulty falling or staying asleep or restless, unsatisfying sleep v.
- •Being easily moved to tears vi.
- •Anticipating the worst vii.
- •Hopelessness viii.
- •Hyper vigilance x.
- •Irritability.
排除标准
- •Patients having severe anxiety or depression according to Hamilton rating scale (especially with suicidal ideation)
- •Drug abuser or any medication causing direct psychological effect.
- •Patient having past history of major depressive disorder (including an anxiety or mood disorder, in partial remission)
- •Presence of any mental disorder other than MADD.
- •Patients with diseases requiring long term treatment Known cases of hyperthyroidism, CVD, renal and liver diseases.
- •Severe anxiety or depression according to the Hamilton Rating Scale.
- •Pregnancy and lactation.
结局指标
主要结局
Improvement in the signs and symptoms of Malankhuliya (Mixed Anxiety Depressive Disorder). Which will be assessed on the basis of Hamilton’s Anxiety rating scale and Hamilton’s Depression rating scale.
时间窗: At baseline, on 1st follow-up, 2nd follow-up and end of the protocol therapy. (i.e., 0, 2nd, 4th and 6th week)
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.(At baseline, on 1st follow-up and end of the protocol therapy. (i.e., 0, 2nd and 6th week))
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)