| CTRI Number |
CTRI/2025/12/099750 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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A Comparative Study to Evaluate the Effect of Leech Therapy and Ibuprofen with Isometric Exercise in Patients Suffering from (Knee) Osteoarthritis. |
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Scientific Title of Study
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A Comparative Clinical Study to Evaluate the Efficacy of Leech Therapy VS NSAIDs (Tab Ibuprofen) and Isometric Exercise in the Management of Sandigatavata with Special Reference Osteoarthritis. |
| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HemRaj |
| Designation |
Principal and Professor |
| Affiliation |
Desh bhagat Ayurvedic college , Amloh Road , Mandi Gobindgarh , district Fatehgarh , Punjab |
| Address |
Department of Ayurveda, Room no 10 ,Ground floor , Administrative Block, Desh Bhagat Ayurvedic college, Desh Bhagat University,Amloh Road, Mandi gobindgarh, district Fatehgarh ,Punjab
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
9418004077 |
| Fax |
|
| Email |
hemraj22@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr HemRaj |
| Designation |
Principal and Professor |
| Affiliation |
Desh bhagat Ayurvedic college , Amloh Road , Mandi Gobindgarh , district Fatehgarh , Punjab |
| Address |
Department of Ayurveda, Room no 10 ,Ground floor , Administrative Block, Desh Bhagat Ayurvedic college, Desh Bhagat University,Amloh Road, Mandi gobindgarh, district Fatehgarh ,Punjab
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
9418004077 |
| Fax |
|
| Email |
hemraj22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HemRaj |
| Designation |
Principal and Professor |
| Affiliation |
Desh bhagat Ayurvedic college , Amloh Road , Mandi Gobindgarh , district Fatehgarh , Punjab |
| Address |
Department of Ayurveda, Room no 10 ,Ground floor , Administrative Block, Desh Bhagat Ayurvedic college, Desh Bhagat University,Amloh Road, Mandi gobindgarh, district Fatehgarh ,Punjab
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
9418004077 |
| Fax |
|
| Email |
hemraj22@gmail.com |
|
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Source of Monetary or Material Support
|
| Desh Bhagat Ayurvedic college , Desh Bhagat University, Amloh Road, Mandi gobindgarh , district Fatehgarh , Punjab |
|
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Primary Sponsor
|
| Name |
Desh Bhagat Ayurvedic college |
| Address |
Desh Bhagat University, Amloh Road, Mandi gobindgarh , district Fatehgarh , Punjab |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi |
Premadhar Research Institute and hospital |
OPD No 2, Ground floor, Premadhar hospital ,Premadhar Research Institute and hospital,Deep Vihar, sector 24 extension, Rohini, Delhi, 110042
North West
DELHI |
7082188705
poonianidhi1@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Leech therapy | (Procedure Reference: , Procedure details: Leech therapy in sandigata vata , 8 sitting in 2 months with gap of 7 days )
| | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Ibuprofen | Tab Ibuprofen 600 mg BD daily for 2 months and isometric exercise daily for 2 month |
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from classical sign and symptoms of Sandhigatavata are Shula, Shotha, Stambha, Sparsha-asahyata, Sphutana, Akunchana Prasarana Vedana etc. at the osteoarthritis of knee joints.
2. Patients between age group of 40 - 70 years.
3. Patients willing to undergo trial. |
|
| ExclusionCriteria |
| Details |
1. Age below 40 years and above 70 years
2. Patients having any previous surgical procedure of knee joint
3. Grade 4 (Severe) large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends
4. Co-existence of lesions to knee joint
5. Patients suffering from disease like Diabetes mellitus., Carcinoma, Psoriatic arthritis, Vata Rakta, systemic lupus erythematosus, Polymyalgia &Tuberculosis will be excluded.
6. Malignant and Immuno-compromised patients AIDS, HBsAg.
7. Pregnant women and lactating mothers |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Janusandigatvata will be cured with leech therapy |
Baseline day, 14th day, 28th day, 42nd day, 60 th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Pain and swelling will be reduced in osteoarthritis (Knee joint) patient |
Baseline day , 14 th day, 28th day , 42nd day, 60th day |
|
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Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
14/01/2026 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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This study is proposed as part of the PhD research/ thesis work of Dr Nidhi
Osteoarthritis is the most common degenerative disorder. Prevalence is high in the old age and the high rate of disability. • Among those 60year old, about 10% of males and 18% of females are affected with Osteoarthritis. Affected individual, osteoarthritis is the cause of about 2% of years lived with disability. • Osteoarthritis is an important cause of disability and second most common musculoskeletal problem in the world (30%) after back pain (50%). This is by far the most common type of arthritis. • It is defined as a condition of synovial joints, characterized by focal loss of articular hyaline cartilage with proliferation of new bone and remodeling of joint contour. • These all-changes cause pain which restricts the person daily activities and become an insurmountable problem for the person. • Ayurveda has also elicited the knee joint pain in the term of janu Sandhigatavata which is a vata vyadi. When vatapredominates and gets trapped in the sandhi it produces ruja(i.e pain) • Osteoarthritis can be correlated with Sandhivata in Ayurveda. Charaka had described this Vyadhi under Vataj NanatmajVyadhi . Acharya Charaka narrated this condition with symptoms such as inflammation, difficulty while walking and pain while walking, and crepitus present in joint. Contemporary treatment has its own limitation in managing thedisease. In Western science, various treatment options in the Osteoarthritis are present but they do not provide remarkable recovery and cause various side effects. So, there is a need to find effective management in Sandhivata. • Recent studies also establised effect of leech therapy in Osteoarthritis, and it is trending now in foreign countries. • Osteoarthritis is a common troubling condition. Yet the disease is not fatal, but its duration & attack makes patient uncomfortable. The incidence of osteoarthritis in India is 12%. It is estimated that approx 4 out of 100 people are affected by Osteoarthritis. Osteoarthritis is the common articular disorder begins asymptomatically in the second & third decades and is common by age 70. year Mostly individual by age 40 have some pathologic change in weight bearing joint, 25% of females & 16% of males have symptomatic osteoarthritis. Western science has its own limitation in managing the disease. This disease is managed by NSAIDs, analgesic, physiotherapy, corticosteroids etc. Above drugs are very costly and cause such as nausea, acidity, vomiting diarrhea etc. These treatments also affect liver and kidneys. Even the surgical managment does not provide complete relief & quite expensive which could not be affordable by every individual. This is a chronic condition that cannot be cured completely. So, a need for search of alternative methods in the management of OA is the need of the hour. • The saliva of leech contains numerous biological active substances which have anti-inflammatory as well as anesthetic property. 5 • Since Osteoarthritis has become a leading problem in majority of population, the pain caused by it limits the activities of the person and degrades the quality of life of the able and working population. So, a convenient, easy and fast acting method to treat the Osteoarthritic pain is the need of the hour. • Also, the need of the study is to find out the extent of effectiveness of leech therapy in management of Osteoarthritis
Clinical Study: Leech therapy Comparative Study will be conducted to assess the efficacy of leech therapy vs NSAIDs ((Tab ibuprofen 600mg) & isometric exercise in the management of janu sandhigata vataW.S.R to Osteoarthritis of knee joint CLINICAL STUDY AIM: - To compare and evaluate the efficacy of leech therapy vsNSAIDs (Tab ibuprofen 600mg) & isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint. OBJECTIVE: - To evaluate the effect of leech therapy vs NSAIDs (Tab ibuprofen 600mg) and isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint. - To compare the effect of leech therapy vs NSAIDs (Tab ibuprofen 600mg) and isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint. RESEARCH QUESTION: • Will leech therapy will be effective in the management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint HYPOTHESIS: NULL HYPOTHESIS H0: Leech therapy is not effective in management of janusandhigata vata W.S.R to Osteoarthritis of knee joint. ALTERNATIVE HYPOTHESIS • H1 Leech therapy is equally effective to NSAIDs (Tab ibuprofen 600mg) and isometric exercise in management of janu sandhigata vata W.S.R to Osteoarthritis of knee joint. • H2- Leech therapy is more effective to NSAIDS (Tab ibuprofen 600mg) and isometric exercise in management of janusandhigata vata W.S.R to Osteoarthritis of knee joint.
CLINICAL STUDY STUDY DESIGN: It will be a Randomized clinical study. SAMPLE SIZE- Total 160 patients will be randomly selected for the study, with ages ranging from 40 years to 70 years, irrespective of gender, religion, occupation, socio- economic status etc. CLINICAL SOURCE - Patients attending OPD and IPD of Premadhar research institute and hospital, Delhi will be selected for the study. During the course of selection and treatment, a separate case Performa according to the protocol will be used for documentation. • EXPERIMENTAL SOURCE - It is a human clinical trial; no animal experimentation will be done. - SAMPLE SIZE: - 160 patients - Two groups of 80 patients each. - Group A: Leech therapy - Group B: NSAIDs (Tab ibuprofen 600mg) and isometric exercise - DURATION OF STUDY – 2 month 8 sittings with the gap of 7 days Follow up:, 14th ,28th , 42th , 60th day NSAIDS (Tab ibuprofen 600mg BD) daily 2 month Isometric exercise daily for 2 month ASSESSMENT PARAMETERS FOR OA CRITERIA FOR ASSESSMENT The improvement in the patient will be assessed mainly on the basis of relief in the signs and symptoms of the disease. To assess the effect of therapy objectively, all the signs and symptoms will be given scoring depending upon their severity. SUBJECTIVE 1. Vedana (pain) 2. Stiffness (sandhigraha) OBJECTIVE 1. Sparsha asahyata (tenderness) 2. Akunchana prasaranajanya vedana 3. Sandhi sphutana (crepitus) 4. Shrama asahyata 5. Shotha (swelling) in joint SUBJECTIVE 1) VEDANA (PAIN) SCORE – VAS SCALE 0- No pain. 1-3 - Mild. 4-6 - Moderate 7-10- Severe STIFFNESS (SANDHIGRAHA) No stiffness - 0 Mild stiffness - 1 Moderate stiffness - 2 Severe difficulty due to stiffness - 3 Severe stiffness more than 10 minutes – 4 OBJECTIVE SPARSHA ASAHYATA (TENDERNESS) No tenderness - 0 Patient says tenderness - 1 Winching of face on touch - 2 Does not allow to touch the joint - 3 AKUNCHANA PRASARANAJANYA VEDANA No pain - 0 Pain without winching of face - 1 Pain with winching of face - 2 Prevent complete flexion - 3 Does not allow passive movement - 4 SANDHI SPHUTANA (CREPITUS) No crepitus - 0 Palpable crepitus - 1 Audible crepitus - 2 SHRAMA ASAHYATA Shrama Sahyata - 0 Mild Shrama Ashahyata - 1 Moderate Shrama Asahyta - 2 Severe Shrama Asahyata – 3 SHOTHA (SWELLING) IN JOINT No swelling - 0 Slight swelling - 1 Moderate swelling - 2 Severe swelling - 3 SWELLING • Knee joint measurement with measuring tape. • Middle point of patella, 2 inches above patella and 2 inches below patella will be measured.
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