Clinical Validation of Unani Pharmacopoeial formulations – Majun Jograj Gugal and Raughan-e-Malkangani in Waja‘al-Mafasil (Rheumatoid Arthritis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Improvement in signs and symptoms of Waja‘al-Mafasil (Rheumatoid Arthritis)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Waja‘al-Mafasil (Rheumatoid Arthritis). Patients will receive the study drug Majun Jograj Gugal as oral and Raughan-e-Malkangani as local application twice daily for a period 12 weeks. All the laboratory parameters will be recorded at baseline and at the end of the study.
Composition of Majun Jograj Gugal(NFUM-I, Page 129-30)
| S. No. |
Ingredients
Botanical Name
Quantity
|1.
Muqil
Commiphora mukul
750 g
|2.
Post-e-Halela Kabli
Terminalia chebula
170 g
|3.
Post-e-Balela
Terminalia bellerica
170 g
|4.
Aamla
Emblica officinalis
170 g
|5.
Waj-e-Turki
Acorus calamus
15 g
|6.
Baharangi
Clerodendrum serratum
15 g
|7.
Atees
Aconitum heterophyllum
15 g
|8.
Kutki
Picrorhiza kurroa
15 g
|9.
Filifil Daraz
Piper longum
15 g
|10.
Maror Phali
Helictres isora
15 g
|11.
Baobarang
Embelia ribes
15 g
|12.
Inderjao Talkh
Holerrhena antidysenterica
15 g
|13.
Tukhm-e-Sambhalu
Vitex negundo
15 g
|14.
Zeera Safaid
Cuminum cyminum
15 g
|15.
Zeera Siyah
Carum carvi
15 g
|16.
Tukhm-e-Karafs
Apium graveolens
15 g
|17.
Hilteet
Ferula foetida
15 g
|18.
Peepal Chab
Piper chaba
15 g
|19.
Sheetraj Hindi
Plumbago zeylancia
15 g
|20.
Filfil Moya
Piper longum
15 g
|21.
Zanjabil
Zingiber officianale
15 g
|22.
Qand Safaid
2.4 kg
|23.
Raughan Zard
QS
|24.
Raughan-e-Sarson
Brassica campestris
QS
Composition of Raughan-e-Malkangani(NFUM-I, Page 197)
| S. No. |
Ingredients
Botanical Name
Quantity
|1.
Malkangani
Celastrus paniculatus
QS
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •â€¢Patients of either sex in the age group 18-65 years.
- •â€¢Patients having Waja‘al-Mafasil (rheumatoid arthritis) as defined by the following ACR-EULAR criteria (Annexure IV): 1)Definite clinical synovitis (pain, swelling, tenderness) in at least 1 joint 2)Absence of an alternative diagnosis for the observed synovitis (arthritis) 3)A total score of at least 6 from the individual scores in 4 domains: a.Number and site of involved joints (range 0-5) b.Serological abnormalities (range 0-3) c.Elevated acute-phase reactants (range 0-1) d.Duration of symptoms (range 0-1).
排除标准
- •â€¢Rheumatoid arthritis with extra-articular manifestations, joint deformities, and advanced radiological lesions (e.g. joint subluxation and collapse).
- •â€¢Obese subjects (BMI ≥30) •History or clinical evidence of any systemic inflammatory condition other than RA such as, juvenile chronic arthritis, spondyloarthropathy, IBD, psoriatic arthritis, active vasculitis, or gout that may interfere with evaluation.
- •â€¢History or clinical evidence of any serious systemic illness, DM, TB, disseminated/ complicated herpes zoster (e.g., multi-dermatomal involvement, ophthalmic zoster, CNS involvement, or post-herpetic neuralgia), HIV infection or any other serious and/ or unstable illness that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data.
- •â€¢Are currently receiving or have received intra-articular treatment (e.g., corticosteroids or hyaluronic acid), oral or parenteral corticosteroids, or NSAIDs within 2 weeks of study entry and DMARDs or IFN therapy within 4 weeks prior to study entry or are anticipated to require IFN therapy during the study.
- •â€¢Screening laboratory test values, including SGOT, SGPT, ALP, S.
- •creatinine, B.
- •urea, and uric acid outside the reference range (raised >3 times the ULN) that, in the opinion of the investigator, could pose an unacceptable risk to the participant.
- •â€¢History of hypersensitivity to study drug or any of its ingredients.
- •â€¢Pregnant and lactating women •H/o Addiction (alcohol, drugs).
结局指标
主要结局
Improvement in signs and symptoms of Waja‘al-Mafasil (Rheumatoid Arthritis)
时间窗: 12 WEEKS
次要结局
- Haematological and biochemical assessments for safety(ï‚· Improvement in the feeling of well-being of the patient)