Clinical study on validation of Unani Pharmacopoeial formulation Majoon e Yahya Bin Khalid and Roghan e Naf e Niqras in Niqras (Gout)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Improvement in sign and symptoms of Niqras (Gout)
研究概览
简要总结
This study is designed as a single arm trial in patients with Niqras (Gout). After screening, patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulations Majoon-e-Yahya Bin Khalid and Roghan-e- Naf-e- Warm-e-Niqras. 5gm of Majoon-e-Yahya Bin Khalid shall be given orally twice a day and 2ml of Roghan-e- Naf-e- Warm-e-Niqras shall be applied locally twice a day. Both the formulations will be given for 12 weeks. The patients will be assessed clinically at every 2 weeks of treatment. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 12weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
(A) Composition of Majoon-e-Yahya Bin Khalid48
| S. No. |
Ingredients
Botanical/Scientific Name
Quantity
|1.
Asaroon
AsarumeuropeaumLinn.
75 g.
|2.
Zanjabeel
Zingiber officinaleRosc.
75g.
|3.
Zeera Siyah
CarumcarviLinn.
75g.
|4.
FilfilDaraz
Piper longumLinn.
75g.
|5.
Suranjan Shireen
Colchicum autumnale
75g.
|6.
Sana
Cassia Angustifolia Vahl.
75g.
|7.
QandSafaid
Refined sugar
250g.
(B) Composition of Roghan-e-Warm-e-Naf-e-Niqras47[AR1]
| S. No. |
Ingredients
Botanical/Scientific Name
Quantity
|1.
Babuna
Matricaria chamomilla Linn.
100g.
|2.
Anab-us-Salab
Solanum nigrum Linn.
100g.
|3.
Parsiaoshan
Adiantum capillus-veneris Linn.
100g.
|4.
Ikleel-ul-Malik
TrigonellaUncataBoiss.
100g.
|5.
Barg-e-Hina
Lawsoniainermis Linn.
100g.
|6.
Suranjan
Colchicum luteum Baker*.*
100g.
|7.
Buzidan
Orchis latifoliaLinn.
100g.
|8.
Mughas (MaidaLakri)
LitseachinensisLinn.
100g.
|9.
Gul-e-Khatami
Althaea officinalis Linn.
100g.
|10.
Gul-e-Babuna
MatricariachamonillaLinn*.*
100g.
|11.
Asl-us-Soos
Glycyrrhiza glabra Linn.
100g.
|12.
Irsa
Iris ensataThunb.
80g.
|13.
Aab
Water
5 Lit
|14.
Roghan-e-Kunjad
Sesamum indicum Linn.
Q.S
|15.
Roghan-e-Zeet
Oil of Olea europaea L.
Q.S
|16.
Roghan-e-Tukhm-e-Khashkhaash
Oil ofPapaver somniferum Linn.
Q.S
|17.
Roghan-e-Tukhm-e-Kharpaza
Oil ofCucumismelo Linn.
Q.S
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either sex between the age groups of 18 years to 65 years.
- •Subjects fulfilling the 2015ACR/EULAR-criteria for diagnosis of gout(≥8).
排除标准
- •Acute Gouty arthritis
- •Subjects having any systemic illness requiring long term treatment
- •Pregnant and lactating women
- •Intolerant to therapy
- •Subjects who received any local injection in the previous 3 months.
结局指标
主要结局
Improvement in sign and symptoms of Niqras (Gout)
时间窗: every 2 weeks for twelve weeks
次要结局
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)