Comparative Clinical Validation study of Unani Pharmacopoeial formulation Majoon-e-Mughalliz vs Majoon-e-Piyaz in Surat-e-Inzal (Premature Ejaculation)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Improvement in the signs and symptoms of Surat-e-Inzal (Premature Ejaculation). Which will be assessed on the basis of PEDT (Premature Ejaculation Diagnostic Tool).
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 Surat-e-inzal (Premature Ejaculation) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline and at the end of the treatment ( i.e., 0 & 2nd weeks). The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy ( i.e., 0 & 2nd weeks).
Composition of Majoon-e-Mughalliz:
| S.No. |
Ingredients
Botanical / Chemical name
Part used
Quantity
|1.
Mastagi
Pistacia lentiscus Linn.
Exudates
20 g
|2.
Iklil ul Batam
Pistacia vera Linn.
30 g
|3.
Kateera
Astragalus gummifer
Oleo Gum resin
60 g
|4.
Tabasheer
Bambusa arundinacea (Retz.) Roxb. Syn.: B. bambos Voss
Exudates
60 g
|5.
Heel khurd
Elettaria cardamomum (Linn.) Maton
Fruit
60 g
|6.
Darchini
Cinnamomum zeylanicum Blume
Stem bark
60 g
|7.
Samagh Arbi
Acacia arabica/nillotica Willd.
Oleo gum resin
60 g
|8.
Nishasta Gandum
Triticum aestivum Linn.
Flour
60 g
|9.
Salab Misri
Orchis latifolia Linn.
Root
60 g
|10.
Maghz Chilghoza
Piper attenuatum
Seed
120 g
|11.
Narjeel
Cocos nucifera Linn.
Fruit pulp
200 g
|12.
Maghz Badam
Prunus dulcis (Mill.) D.A. Webb
Seed
240 g
|13.
Asl or Qand Safaid
Honey / Sugar
2.5 Kg
Composition of Majoon-e- Piyaaz
| S.No. |
Ingredients
Botanical / Chemical name
Part used
Quantity
|1.
Tudri surkh
Cheiranthus cheiri L.
Seed
35 g
|2.
Tudri safaid
Matthiola incana R.Br.
Seed
35 g
|3.
Salab Misri
Orchis latifolia L.
Tuber
35 g
|4.
Behman Surkh
Salvia haematodes L.
Root
35 g
|5.
Behman Safaid
Centaurea behen L.
Root
35 g
|6.
Zanjabeel
Zingiber officinale Rosc.
Rhizome
35 g
|7.
Tukhm-e-Piyaz
Allium cepa L.
Seed
35 g
|8.
Tukhm-e-Turb
Raphanus sativus L.
Seed
35 g
|9.
Tukhm-e-Gandana
Allium ascalonicum L.
Seed
35 g
|10.
Tukhm-e-Shalgam
Brassica rapa L.
Seed
35 g
|11.
Talmakhana
Hygrophila auriculata (Schum.)Heine.
Seed
35 g
|12.
Musli safaid
Chlorophytum arundinaceum Baker.
Root
35 g
|13.
Musli siyah
Curculigo orchioides Gaertn.
Root
35 g
|14.
Aab-e-Piyaz Safaid
Allium cepa L.
Onion extract
1.5 lit
|15.
Qand Safaid
Sugar
Crystals
1.5 kg
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
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Men with a PEDT score more than 8
- •Men with lifelong /Acquired PE meeting the evidence-based definition proposed by ISSM in 2013: LPE: i.
- •IELT equal or less than 1 min from the first sexual experience ii.
- •Inability to delay ejaculation iii.
- •Related negative personal consequences, such as distress, bother, frustration, and/or the avoidance of sexual intimacy.
- •A clinically significant reduction in IELT, often equal or less than 3 min ii.
- •Lacking the ability to delay ejaculation iii.
- •Related negative personal consequences as similar with that of LPE.
排除标准
- •Patients with Erectile dysfunction
- •Major psychiatric disorders or cognitive impairments
- •Patients with history of intake of any drug causing sexual dysfunction and affecting psychological status
- •History of addiction (alcohol, drug abuse)
- •Male patients with confirmed hyperthyroidism and diabetes mellitus
- •Patients with chronic diseases requiring long term treatment.
结局指标
主要结局
Improvement in the signs and symptoms of Surat-e-Inzal (Premature Ejaculation). Which will be assessed on the basis of PEDT (Premature Ejaculation Diagnostic Tool).
时间窗: At baseline and at the end of the study. i.e., 0 & 2nd weeks
次要结局
- Haematological and biochemical investigations for safety assessment i.e., Hemogram, ESR, LFT, KFT, Serum Uric Acid,Semen Analysis, Urine Examination: Routine & Microscopic(At baseline and at the end of treatment. i.e., 0 & 2nd weeks)
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)