| 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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad 500038 |
|
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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 |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CRIUM Hyderabad |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
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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
|
|
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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
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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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 |
|
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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 |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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 ‘.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 cauterizationâ€. 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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