Effect of Emesis Unani formulation and massage therapy in Knee pain
- Conditions
- Patients having knee pain
- Registration Number
- CTRI/2018/05/013978
- Lead Sponsor
- National Institute of Unani Medicine
- Brief Summary
*Osteoarthritis* *(Waja-ul-Mafasil)* *is a chronic disorder of synovial joints in which there is progressive softening and disintegration of articular cartilage accompanied by new growth of cartilage and bone at the joint margins, cyst formation and sclerosis in the subchondral bone, mild synovitis and capsular fibrosis. Osteoarthritis is the commonest of all joint diseases and the knee is the commonest of the large joints affected by osteoarthritis. Indians have increased knee osteoarthritis as compared to western people. The reported prevalence of osteoarthritis in rural India is 5.8%. According to World Health Organization (WHO), Osteoarthritis is second commonest musculoskeletal problem in the world population (30%) after back pain (50%).*Ninety percent of all people have radiographic features of osteoarthritis in weight bearing joints by age 40. The main presenting symptoms of osteoarthritis are pain and functional restriction..
The current treatment of osteoarthritis is aimed at *minimising pain, optimizing function and reducing disability using a combination of non pharmacological, pharmacological and surgical therapies. Non pharmacological therapies include patient education and joint protection measures. Pharmacological management includes Non-steroidal anti-inflammatory drugs (NSAIDs) which are used to treat pain and inflammation in OA. Their use is limited by their gastric and renal toxicity, especially in the elderly. Intra-articular steroids are employed in patients with knee OA who have effusion. Repeated steroid injections may lead to more cartilage damage. Surgical management includes joint replacement in end stage joint disease. Other surgical therapies available are with varying grades of efficacies.*
*Thus, no curative therapy exists for osteoarthritis. In view of high prevalence, obnoxious side effects of pharmacological treatment and high cost of surgical interventions with less effectiveness of all treatment modalities, there is need for search of safe, economic and effective treatment in Unani system of Medicine for osteoarthritis, particularly of a knee joint. Various treatments are described in Unani Literature for* *Waja-ul-Mafasil**. Hakim Muhammad Azam Khan mentioned* *Qai, Munzij wa Mus’hil-e-Balgham* *in management of* *Waja-ul-Mafasil**. Further he mentioned* *Dalk* *with* *Roghan-e-Chobchini.*
This open, pre and post clinical study wasstarted after ethical clearance from IEC. Patients fulfilling inclusioncriteria were enrolled in the study from OPD and IPD of NIUM Bengaluru afterobtaining written informed consent. 30 patients completed the trial. *Qai* wasinduced on the 1st day of treatment by *Joshanda* of *Tukhm-e-Shibt*and *Aslussoos* mixed with honey. From 2nd day, *JoshandaMunzij-e-Balgham* (containing *Aslussoos, Tukhm-e-Kasni, Maweez Munaqqa, Tukhm-e-Kharpaza,Tukhm-e- Khatmi, Suranjan Shireen, Boozidan, Anisoon, Badranjboya,Parsiyaoshan, Favvah*) was administered till 15th day oftreatment. *Joshanda Mus’hil-e-Balgham*, containing *Barg-e-Sana,Turbud, Zanjabeel, Barang Kabli, Maghz Khayar Shambar*, was given on 13thand 15th day along with *Joshanda Munzij-e-Balgham*. From 16thday onwards, *Dalke Layyin Kaseer* was started with *Roghan-e-Chobchini*till 30th day. Patients were assessed at baseline, 15thday and 30th day using objective parameters KOOS and VAS. Safetyparameters were assessed before and after the study. The Statisticalsoftware namely SPSS 18.0, and R environment ver.3.2.2 were used for theanalysis of the data. Student *t* test (two tailed, dependent) has beenused to find the significance of study parameters as well as safety parameters.
Itwas observed that VAS score was reduced significantly after treatment. VASscore in right knee was reduced from 6.86±1.48 to 3.45±1.40.Result was found statistically significant (p < 0.001). VAS score in leftknee reduced from 6.79±1.50 at baseline to 3.17±1.10 after treatment. The meandifference was highly significant (p<0.001)
Assessment of symptoms, pain, ADL, sports/recreation and Quality of lifewas done by using KOOS which showed significant improvement. Symptoms improvedsignificantly from 44.38±17.86 to 69.07±12.36in the right kneeand from 46.66±16.65 to 71.00±11.07 in the left knee after the treatment.Pain in the right knee improved from 37.83±18.09 to 66.83±13.56 and in theleft knee it showed significant improvement from 38.79±19.25 to67.76±14.20. ADL improved significantly from 41.00±17.06 to 64.31±16.20 in right knee and also improved significantly from 41.31±17.07 to 66.00±14.48 in left knee. Sports/recreation subscale score improved significantlyfrom 32.24±16.93 to 63.28±11.28in right knee and from 33.28±18.63 to 63.45±12.33 in the left knee, which was stronglysignificant statistically. Quality of life score improved significantly from 24.93±13.68to 59.30±12.94.
Properties of various ingredients of the test formulation stronglysuggest the potential to treat the sign and symptoms of *Waja-ur-Rukba*and, therefore, validated their efficacy in this trial. The study involving *Qai,Munzij wa Mus’hil-e-Balgham* and *Dalk* with *Roghan-e-Chobchini*was found effective in treating *Waja-ur-Rukba* (knee osteoarthritis).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Inclusion Criteria: 1.Both genders.
- 2.Age group 40 to 60 years.
- ACR criteria (Clinical and Radiographic criteria) i.Knee pain for most days of prior month ii.Osteophytes at joint margins iii.Synovial fluid typical of osteoarthritis iv.Age ≥ 40 years v.Morning stiffness lasting ≤ 30 min vi.Crepitus with active joint motion Diagnosis requires: i+ii, or i+iii+v+vi, or i+iv+v+vi.
- Exclusion criteria : 1.
- Pregnancy and lactation 2.Patients with systemic and metabolic diseases 3.Patients of knee joint pathology other than osteoarthritis 4.Patients with the history of trauma and accidents involving knee joints 5.Known cases of gastric ulcer and esophageal varices.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain subscale of KOOS baseline, 15th day and 30th day
- Secondary Outcome Measures
Name Time Method Efficacy of above mentioned regimes on symptoms, activities of daily living, sports and quality of life in knee osteoarthritis. baseline, 15th day and 30th day
Trial Locations
- Locations (1)
National Institute of Unani Medicine
🇮🇳Bangalore, KARNATAKA, India
National Institute of Unani Medicine🇮🇳Bangalore, KARNATAKA, IndiaSayyed Adnan MohammadPrincipal investigator8123068551sayyed224@gmail.com