Comparative Clinical Validation study of Unani Pharmacopoeial formulation Itrifal-e-Muqil Mullaiyan & Roghan e Babuna Qawi vs Habb-e-Suranjan & Roghan e Suranjan in Waja ul Mafasil (Rheumatoid Arthritis)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 210
- Locations
- 3
- Primary Endpoint
- The safety and efficacy of Unani Pharmacopeial formulation Itrifal-e-Muqil Mullaiyan & Roghan e Babuna Qawi in comparison with Habb-e-Suranjan & Roghan e Suranjan in Waja ul Mafasil (Rheumatoid Arthritis) will be carried out on the basis of DAS28 Form
Study Overview
Brief Summary
Rheumatoid arthritis (RA) is a long-lasting inflammatory condition of undetermined causative factors with the hallmark of symmetric joint involvement. It is an autoimmune disorder in which the body’s immune system attacks its own tissue, including joints. Due to the synovial membrane being the primary target of RA, the synovium becomes inflamed and proliferates, articular cartilage is lost, and the bone is eroded. Waja ál-mafasil, an Arabic term made up of the terms "waja" for pain and "mafasil" for joint, is used to explain rheumatoid arthritis in Unani medicine. Waja ál-Mafasil is also referred to as "Hudar". The aim of this trial is assess the safety and efficacy of Unani pharmacopoeial formulation Itrifal-e-Muqil Mullaiyan & Roghan e Babuna Qawi vs Habb-e-Suranjan & Roghan e Suranjan in patients of Waja-ul mafasil (Rheumatoid Arthritis). This study is designed as a Multi centric, Randomized, Parallel Group, Active Controlled trial in patients with Waja ul Mafasil (Rheumatoid Arthritis) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline and every two weeks during the treatment period. (i.e., 0, 2nd, 4th, 6th, 8th, 10th and 12th weeks). The subjective and objective clinical observations will be recorded in the follow-up sheet. The total duration of treatment will be 12 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy (i.e., 0 and 12th weeks).
Itrifal-e-Muqil-Mullaiyan
| S. No |
Ingredients
Botanical Names
Quantity
|1.
Muqil
Commiphora mukul (Hook ex stocks) Engl.
350gm
|2.
Turbud Safaid
Operculina turpethum L Silva Manso.
120gm
|3.
Post-e-Halela Zard
Terminalia chebula Retz.
90gm
|4.
Post-Halela Kabli
Terminalia chebula Retz.
90gm
|5.
Post-e-Balela
Terminalia bellerica Roxb
90gm
|6.
Halela Siyah
Terminalia Chebula Retz
90gm
|7.
Aamla
Emblica officinalis Gaertn.
90gm
|8.
Mastagi
Pistacia lentiscus Linn
50gm
|9.
Raughan-e-Badam Shireen
Or
Raughan Zard
Prunus Amygdalus Dulcis
150gm
|10.
Asal or Qand Safaid
Honey
3.5kg
|11.
Aab-e-Gandana
Allium ascalonium L.
Q.S.
Roghan e Babuna Qawi
| S. No |
Ingredients
Botanical Names
Quantity
|1.
Sumbul-ut-Teeb
Nardostachys jatamansi D.Don. DC.
12 g
|2.
Bisbasa
Myristica fragrans Houtt.
12 g
|3.
Heel khurd
Elettaria cardamomum Maton
12 g
|4.
Hamama
Amomum racemosum L.
12 g
|5.
Tukhm-e-Katan
Linum usitatissimum L.
12 g
|6.
Ikleel-ul-Malik
Trigonella uncata Boiss. & Noe Lassen
12 g
|7.
Babuna
Matricaria chamomilla L.
48 g
|8.
Aab
Water
12 times of all the ingredients
|9.
Roghan-e-Kunjad
Sesamum indicum L.
Equal to all ingredients
Comparator group
Habb –e-Suranjan
| S. No |
Ingredients
Botanical Names
Quantity
|1.
Suranjan
Colchicum luteum Baker.
1 part
|2.
Post e Halela Zard
Terminalia chebula Retz
1 part
|3.
Shahm e Hanzal
Citrullus colocynthis (L.) Schrad
1 part
|4.
Muqil
Commiphora mukul (Hook ex Stocks) Engl.
1 part
|5.
Trurbud
Operculina turpethum (L) Silva Manso.
1 part
Roghan e suranjan
| S. No |
Ingredients
Botanical Names
Quantity
|1.
Suranjan
Colchicum luteum Baker.
50 g
|2.
Aab e karafs
Apium graveolens L.
50 g
|3.
Chiraita
Swertia chirata Buch. Ham exWall
50 g
|4.
Roghan e zaitoon
Olea europaea L.
150 g
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients fulfilling the 2010 ACR-EULAR Rheumatoid Arthritis Classification Criteria.
Exclusion Criteria
- •1.Severe cases of RA (Stage III & IV) & diagnosed cases of ankylosing spondylosis/ Gout.
- •2.Cases with systemic manifestation of Rheumatoid arthritis.
- •Abnormality in any investigation done at baseline (SGOT, SGPT and ALP, Sr Creatinine, B.
- •Urea would be considered abnormal if raised more than 2.5 times the normal value), also Patients with GFR less than 60 will be exclude from the study.
- •Patient with High grade fever.
- •Disorders requiring long term treatment.
- •Patient is on treatment for any illness related to Endocrine & metabolic disorders.
- •Pregnancy and lactation.
- •Drug addicts (Alcohol, drugs).
Outcomes
Primary Outcomes
The safety and efficacy of Unani Pharmacopeial formulation Itrifal-e-Muqil Mullaiyan & Roghan e Babuna Qawi in comparison with Habb-e-Suranjan & Roghan e Suranjan in Waja ul Mafasil (Rheumatoid Arthritis) will be carried out on the basis of DAS28 Form
Time Frame: At baseline and every two weeks during the treatment period. (i.e., 0, 2nd, 4th, 6th.8th, 10th and 12th weeks).
Secondary Outcomes
- Haematological and biochemical investigations for safety assessment i.e., Hemogram, LFT,KFT, Urine Examination: Routine & Microscopic.(At baseline and at the end of treatment. i.e., 0 and 12th week)
Investigators
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)