Clinical study of Qurs-e-Mafasil Jadeed with and without Hijama in knee joints pain

Phase 2

Recruiting

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2019/04/018450
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

Osteoarthritis isthe most widespread and common chronic musculoskeletal disorders and is amajor cause of morbidity, limitation of activity, and healthcareutilization, especially in elderly patients (OA) of the knee. Thenumber of people affected with osteoarthritis is rising in the whole world asthe dominance of risk factors such as obesity, poor levels of physical fitnessand years of life expectancy are persistently increasing.

Currentrecommendations for managing OA focus on relievingpain and stiffness, and maintaining or improving physicalfunction as important goals of therapy. No curative therapies existfor OA; both pharmacologic and non- pharmacologic management focus oncontrolling pain and reducing functional limitation. Pharmacologictherapies include non-opioid analgesics (such as acetaminophen), NSAIDs(including COX-2 enzyme selective inhibitors), topical analgesics (capsaicincream), opioid analgesics, and intra-articular steroid andhyaluronate injections. Pharmacologic management is full of adverseeffects (hepatotoxicity, nephrotoxicity, hematological toxicity etc.

Unani medicineoffers a large variety of pharmacological and regiminal therapies for themanagement osteoarthritis. There is a long list of single and compound drugsand also regimental therapy such as Fasad (venesection), Irsaal-e-alaq (leechtherapy), hijama (cupping) etc. which are mentioned in Unani literature to beuseful in waja-ul-mafasil. Hijama.

In Unaniliterature, osteoarthritis is not mentioned as such, but by comparing the signsand symptoms of Osteoarthritis it can be concluded that Waja-ul-Mafasil Baridhave more resemblance with it.

As per the Unanidoctrine derangement of the humoral temperament is occurred due to the presenceof morbid humours/matters in the blood circulation which is responsible for thedisease. Hence Cupping therapy is applied for the purpose of elimination ofmorbid material (Tanqiya-e-Mawad) from the body. Various eminent Unaniphysician has recommended cupping for the treatment of arthritis. in theirrespective text

Ali-Ibne-Abbas-Majoose-hasreported cupping to be significantly beneficial in the treatment of arthritisand he has also listed the methods for the same.in his famous bookKamil-us-Sana, he says ‘for the treatment of Waja ul Mafasil, at first,Mahajjama Bila Shurt Should be applied and should be sucked with great force.After this, Hurt Should be applied, and Mahejjama should be applied at thepoint nearest to the joint’9.

1) Al-RaaziQuotes in his book Al Havi Al Kabeer, in the treatment of Hip joint arthritis,When Humours are thick and difficult to evacuate, the use of mahajjama isadvised and it is very beneficial

2) Razi describedAhran, who, while describing wajaul warik, has quote mahajjama as being themost important and the most beneficial. He further says that if this(application of Mahajjama) is preceded by the use of advia Harra ,than it isstill better

3) Ibne Sina says, cupping below the knee is beneficial in such trouble of the knee whichresults from acute humars11 â€˜.Has also stated the mahajjama to be apossible beneficial treatment for arthritis. He is quoted by Razi in his bookAl Havi

4) Ibne –ul-kahaf  in his book kitabul umda fil jarahat, hs described the metghod ofcupping in the treatment  of arthritis. He sdays, ‘the method of cuppingon the knee is such that the patient keeps his legs on the ground and Mahajjamais applied at the point of knee joint on the lower end of the femur. This helpsin treating arthritis of the knee

 In this treatmentmodality, suction is created by various means Cupping may be done either wet ordry. Dry cupping is simply placing the suction cups on the skin. Wet cupping,or cupping with Scarification is a form of bloodletting procedure that involvesan incision on the skin, then applying the suction cups to suck out of blood.

Though thistherapy is being widely practiced across the globe for treating many chronicand intractable ailments Many of the therapeutic uses raised the questionsabout cupping therapy about its principals of action, how it works and to whatextent it may be beneficial. Therefore, Searching for a better conservativeeconomic and effective line of treatment and to develop standard operativeprocedures of cupping therapy in various diseases is the need of the hour.

religious textsand sayings about Hijama (cupping) also attracted the attention of researchersto the scientific values Prophet Mohammad peace be upon him recommended cuppingtherapy as a treatment: “If there is a benefit in any of your treatmentmodalities, benefit will be in the blade puncture in cupping therapy, a gulp ofhoney and cauterizing, but I do not like cauterizationâ€. This further motivatedus to search and establish the novel evidence-based scientific mechanism ofaction of cupping therapy and how effective is this therapy in differentdiseases.

Biomarkersof Osteoarthritis:

Osteoarthritis(OA) is a slowly progressive degenerative joint disease that is traditionallyassociated with radiographic signs of joint space narrowing, osteophytesformation, and subchondral sclerosis. Its main clinical symptoms are variablejoint pain and stiffness, and occasional effusion. However, radiographic signsand clinical symptoms only develop in late-stage OA when significant jointdamage has already occurred. Development of disease modifying treatmentmodalities for OA is challenging; lack of in-depth understanding of diseasepathogenesis, the slowly progressive character of OA, the insensitivity ofmonitoring methods, and the limited relation between pain, disability andstructural changes, still necessitate long and large-scale therapeutic trials.Therefore, current treatment strategies are limited and mainly based onanalgesics and, eventually, surgical procedures. Biochemical markers can supposeto elucidate joint changes more directly and early than   imaging andalso provide a direct measure of drug and intervention effect Biomarkers aredefined as characteristics that are objectively measured and evaluated asindicators of normal biological processes, pathogenic processes, orpharmacologic responses to therapeutic interventions. A lot of effort has beenput into the development of biochemical markers that can aid diagnosingearly-stage OA, predicting OA progression, and assessing therapeutic response.Serum cartilage oligomeric matrix protein (COMP) and serum Hyaluronic acid (HA)are the two diagnostic biomarkers which are most often used. Theavailability of such biochemical markers could be used to diagnose thecondition in early stage and to assesses the disease progression and efficacyof treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-15
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients of any sex aged 40-70 years Patients having Moderate to severe Knee pain (pain more than 40 mm and less than 90 mm) after 50 feet Walking on a flat surface Patients of Knee OA with chronicity of more or equal to 6 months Patients having K L Grading criteria of grades II or III Patients with normal laboratory values.
• Patients willing to comply with the regular treatment schedule as per protocol.

Exclusion Criteria

• Anemia (less than 10g percent of Hb) and bleeding disorders Pregnant and Lactating Mothers Another type of arthritis, eg Rheumatoid arthritis, Psoriatic arthritis, Gouty arthritis Patients taking Anticoagulants, corticosteroid or NSAIDs or any other concomitant therapy History of Surgery, Tidal lavage/Arthroscopy of the joint involved, of affected knee within the past 1 year.
• Intra-articular (IA) corticosteroid injection of affected knee within a 3 months interval prior to baseline screening Patients with the gastro-intestinal disease, peptic ulcer and having fecal blood loss History of Systemic illness such as Liver, Kidney, Cardiac disorders, DM, HTN, Osteomyelitis, Tuberculosis, Known cases of Immunocompromised states (HIV or AIDS, etc.)/ Malignancies Patients who were not willing to be randomized Ongoing use of prohibited medication including NSAID, another oral analgesic, muscle relaxant, or a low-dose antidepressant for any chronic pain management Concomitant skin disease at the application site History of alcohol or Drug abuse, excessive smoking, Diagnosed neurological or psychiatric disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tenderness on the joint area	At baseline, 2wk, 4wk, 6wk and end of the 8wk
Effusion and Swelling over the affected joint	At baseline, 2wk, 4wk, 6wk and end of the 8wk
Range of movements (Goniometry)	At baseline, 2wk, 4wk, 6wk and end of the 8wk
Walking time	At baseline, 2wk, 4wk, 6wk and end of the 8wk

Secondary Outcome Measures

Name	Time	Method
X-ray grading	Biomarkers used

Trial Locations

Locations (1)

Central Research Institute of Unani Medicine; 🇮🇳 Hyderabad, TELANGANA, India

Central Research Institute of Unani Medicine

🇮🇳Hyderabad, TELANGANA, India

Zaki Ahmad Siddiqui

Principal investigator

7351856860

zakiahmad001@gmail.com