Immunological study on Unani Pharmacopoeial drugs Majun Jograj Gugal and Raughan-e-Malkangani to validate their Anti Inflammatory and Anti Arthiritic property in the cases of 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
- 1
- 主要终点
- This study will Scientifically validate, anti-inflammatory and anti-arthritic property of Majoon Jograj Goggul and Roghan Malkangani by using some immunological markers of inflammation and arthritis
研究概览
简要总结
Thepresent proposal is open labelled and will be undertaken to scientificallyvalidate the efficacy claims of Unani Pharmacopoeial drugs Majoon Jograj Goggul andRoghan Malkangani to investigate immunological tools such as IL-1b,IL-6, TNF-a, IL-11, IL-17, HighsensitiveC-reactive proteins, Rheumatoid Arthritis factor, before and after treatment ofthese Unani Pharmacopoeial drugs in the patients of waja-al-Mafasil(Rheumatoidarthritis) registered in Regional research institute of Unani medicine Patna.These immunological studies are proposed to strengthen the efficacy claim ofthese Unani Pharmacopoeial drugs.
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
Procurement, storage anddispensing
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
This study will Scientifically validate, anti-inflammatory and anti-arthritic property of Majoon Jograj Goggul and Roghan Malkangani by using some immunological markers of inflammation and arthritis
时间窗: 12 weeks
次要结局
- This study will help us to know the status of these Immunological markers of arthritis such as IL-1β, IL-6, IL-11, TNF-α IL-17, high sensitive C-reactive protein and rheumatoid factor in cases in cases of Waja‘ al-Mafasil (Rheumatoid Arthritis)(and its modulation by unani pharmacopoeal formulations)