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CTRI Number  CTRI/2019/04/018450 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On: 12/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical study of Qurs-e-Mafasil Jadeed with and without Hijama in knee joints pain 
Scientific Title of Study   A randomized, controlled, open label, triple arm, prospective clinical study for therapeutic evaluation of Qurs-e-Mafasil Jadeed with and without Hijama bi’l Shart (Wet cupping) in knee Osteoarthritis with special reference to selective Biomarkers  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KO/QMJ/WC/RCT/CCRUM/17-18, Version:01, 25/07/2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zaki Ahmad Siddiqui 
Designation  PhD Scholar 
Affiliation  Central Research Institute of Unani Medicine 
Address  GOPD No.- 001, Ground Floor, New OPD Block, Dept. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, A.Gs Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  7351856860  
Fax    
Email  zakiahmad001@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arzeena Jabeen 
Designation  Research Officer III 
Affiliation  Central Research Institute of Unani Medicine 
Address  ROPD No.- 002, Ground Floor, Main OPD Block, Dept. of Baras, Central Research Institute of Unani Medicine, Opp. ESI Hospital, A.Gs Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  9032519286  
Fax    
Email  aarzu763@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tasleem Ahmad 
Designation  Research Officer (Biochemistry) 
Affiliation  Central Research Institute of Unani Medicine 
Address  Room No.- 008, Ground Floor, Main Building, Dept. of Biochemistry, Central Research Institute of Unani Medicine, Opp. ESI Hospital, A.Gs Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  9304109801  
Fax    
Email  tasleem786@rediffmail.com  
 
Source of Monetary or Material Support  
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad 500038 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine 
Address  61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi, Delhi 110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Zaki Ahmad Siddiqui  Central Research Institute of Unani Medicine  Ground floor, Gen OPD-2 Dept. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda
Hyderabad
TELANGANA 
7351856860

zakiahmad001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee CRIUM Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Qurs-e-Mafasil-jadeed in the dose of 2 pills (500 mg each) daily orally with water after meals 
Intervention  Group B (Unani Drug and Hijama Bil-Shart)  Qurs-e-Mafasil-jadeed in the dose of 2 pills (500 mg each) daily orally with water after meals along with Hijama Bil-Shart Weekly for 8 sittings 
Comparator Agent  Group C (Acetaminophen)  Tab. Acetaminophen 650 mg Dose: One tablet (650 mg) twice daily orally with water after meals  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Tenderness on the joint area
Effusion and Swelling over the affected joint
Range of movements (Goniometry)
Walking time  
At baseline, 2wk, 4wk, 6wk and end of the 8wk 
 
Secondary Outcome  
Outcome  TimePoints 
X-ray grading
Biomarkers used
Assessment of safety 
At baseline and end of the 8wk 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Osteoarthritis is the most widespread and common chronic musculoskeletal disorders and is a major cause of morbidity, limitation of activity, and healthcare utilization, especially in elderly patients (OA) of the knee. The number of people affected with osteoarthritis is rising in the whole world as the dominance of risk factors such as obesity, poor levels of physical fitness and years of life expectancy are persistently increasing.

Current recommendations for managing OA focus on relieving pain and stiffness, and maintaining or improving physical function as important goals of therapy. No curative therapies exist for OA; both pharmacologic and non- pharmacologic management focus on controlling pain and reducing functional limitation. Pharmacologic therapies include non-opioid analgesics (such as acetaminophen), NSAIDs (including COX-2 enzyme selective inhibitors), topical analgesics (capsaicin cream), opioid analgesics, and intra-articular steroid and hyaluronate injections. Pharmacologic management is full of adverse effects (hepatotoxicity, nephrotoxicity, hematological toxicity etc.

Unani medicine offers a large variety of pharmacological and regiminal therapies for the management osteoarthritis. There is a long list of single and compound drugs and also regimental therapy such as Fasad (venesection), Irsaal-e-alaq (leech therapy), hijama (cupping) etc. which are mentioned in Unani literature to be useful in waja-ul-mafasil. Hijama.

In Unani literature, osteoarthritis is not mentioned as such, but by comparing the signs and symptoms of Osteoarthritis it can be concluded that Waja-ul-Mafasil Barid have more resemblance with it.

As per the Unani doctrine derangement of the humoral temperament is occurred due to the presence of morbid humours/matters in the blood circulation which is responsible for the disease. Hence Cupping therapy is applied for the purpose of elimination of morbid material (Tanqiya-e-Mawad) from the body. Various eminent Unani physician has recommended cupping for the treatment of arthritis. in their respective text

Ali-Ibne-Abbas-Majoose-has reported cupping to be significantly beneficial in the treatment of arthritis and he has also listed the methods for the same.in his famous book Kamil-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 the point nearest to the joint’9.

1) Al-Raazi Quotes 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 is advised and it is very beneficial

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

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

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

 

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

Though this therapy is being widely practiced across the globe for treating many chronic and intractable ailments Many of the therapeutic uses raised the questions about cupping therapy about its principals of action, how it works and to what extent it may be beneficial. Therefore, Searching for a better conservative economic and effective line of treatment and to develop standard operative procedures of cupping therapy in various diseases is the need of the hour.

religious texts and sayings about Hijama (cupping) also attracted the attention of researchers to the scientific values Prophet Mohammad peace be upon him recommended cupping therapy as a treatment: “If there is a benefit in any of your treatment modalities, benefit will be in the blade puncture in cupping therapy, a gulp of honey and cauterizing, but I do not like cauterization”. This further motivated us to search and establish the novel evidence-based scientific mechanism of action of cupping therapy and how effective is this therapy in different diseases. 

 Biomarkers of Osteoarthritis:

Osteoarthritis (OA) is a slowly progressive degenerative joint disease that is traditionally associated with radiographic signs of joint space narrowing, osteophytes formation, and subchondral sclerosis. Its main clinical symptoms are variable joint pain and stiffness, and occasional effusion. However, radiographic signs and clinical symptoms only develop in late-stage OA when significant joint damage has already occurred. Development of disease modifying treatment modalities for OA is challenging; lack of in-depth understanding of disease pathogenesis, the slowly progressive character of OA, the insensitivity of monitoring methods, and the limited relation between pain, disability and structural changes, still necessitate long and large-scale therapeutic trials. Therefore, current treatment strategies are limited and mainly based on analgesics and, eventually, surgical procedures. Biochemical markers can suppose to elucidate joint changes more directly and early than   imaging and also provide a direct measure of drug and intervention effect Biomarkers are defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic interventions. A lot of effort has been put into the development of biochemical markers that can aid diagnosing early-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. The availability of such biochemical markers could be used to diagnose the condition in early stage and to assesses the disease progression and efficacy of treatment.

 

 
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