[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651946":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":68,"centralContacts":72,"locations":81,"responsibleParty":120,"collaborators":123,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":36,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":148,"whyStopped":36,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Jodhpur","OTHER_GOV",[8,17,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Medical Care","ACTIVE_COMPARATOR","Participants assigned to this arm will receive standard medical management for knee osteoarthritis for 24 weeks. Treatment includes oral paracetamol, topical diclofenac spray administered as required for pain relief, transcutaneous electrical nerve stimulation (TENS), and superficial heat or cold therapy. Participants will be assessed at baseline and followed at 4, 8, 12, 16, 20, and 24 weeks.",[13,14,15,16],"Drug: Topical Diclofenac Spray","Device: Portable TENS","Drug: Paracetamol","Other: Superficial Heat or Cold Therapy",{"label":18,"type":19,"description":20,"interventionNames":21},"Ayurvedic Care","EXPERIMENTAL","Participants assigned to this arm will receive oral Trayodashang Guggulu (1 g twice daily with lukewarm water), Ashwagandha Churna (3 g twice daily with lukewarm water), Janubasti administered according to the predefined schedule, and topical application of Mahanarayana Taila (10 mL per knee; total 20 mL per application) applied twice daily for 24 weeks. Janubasti will be administered in 21 sessions, with 7 sessions during Weeks 1-2, 7 sessions during Weeks 9-10, and 7 sessions during Weeks 17-18. Participants will undergo scheduled follow-up assessments throughout the study.",[22,23,24,25],"Drug: Trayodashang Guggulu","Drug: Ashwagandha Churna","Procedure: Janubasti","Drug: Mahanarayana Taila",{"label":27,"type":19,"description":28,"interventionNames":29},"Integrated Care","Participants assigned to this arm will receive oral Trayodashang Guggulu (1 g twice daily), Ashwagandha Churna (3 g twice daily), topical diclofenac spray as required, and portable transcutaneous electrical nerve stimulation (TENS) for 24 weeks. Participants will undergo scheduled follow-up assessments at Weeks 4, 8, 12, 16, 20, and 24.",[22,23,13,14,16],[31,37,41,46,50,54,59,63],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Trayodashang Guggulu","Trayodashang Guggulu is an Ayurvedic polyherbal formulation administered orally as tablets at a dose of 1 g twice daily with lukewarm water for 24 weeks for the management of knee osteoarthritis.",[18,27],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Ashwagandha Churna","Ashwagandha Churna is an Ayurvedic herbal powder derived from the root of Withania somnifera and administered orally at a dose of 3 g twice daily with lukewarm water for 24 weeks.",[18,27],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"PROCEDURE","Janubasti","Janubasti is an Ayurvedic external therapeutic procedure in which warm Mahanarayana Taila is retained over the affected knee within a dough ring for 30-35 minutes. A total of 21 sessions will be administered, with 7 sessions during Weeks 1-2, 7 sessions during Weeks 9-10, and 7 sessions during Weeks 17-18.",[18],{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"Mahanarayana Taila","Mahanarayana Taila is an Ayurvedic medicated oil applied topically over both knees at a dose of 10 mL per knee (20 mL per application) twice daily for 24 weeks.",[18],{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":36},"Topical Diclofenac Spray","Topical diclofenac spray is a non-steroidal anti-inflammatory drug (NSAID) formulation applied locally over the affected knee as required for symptomatic pain relief during the 24-week intervention period.",[27,9],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":36},"DEVICE","Portable TENS","Portable transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy device that delivers low-voltage electrical stimulation through surface electrodes placed around the affected knee for pain management during the 24-week intervention period.",[27,9],{"type":32,"name":60,"description":61,"armGroupLabels":62,"otherNames":36},"Paracetamol","Paracetamol is a non-opioid analgesic administered orally for symptomatic pain relief during the 24-week intervention period in the Standard Medical Care group and permitted as rescue (SOS) medication for symptomatic pain relief when clinically required in the Ayurvedic Care and Integrated Care groups.",[9],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":36},"OTHER","Superficial Heat or Cold Therapy","Superficial heat or cold will be applied locally to the affected knee as a non-pharmacological intervention for symptomatic management of knee osteoarthritis during the 24-week intervention period.",[27,9],[69],{"name":70,"affiliation":5,"role":71},"Nitesh M Gonnade, MBBS, MD(PMR)","PRINCIPAL_INVESTIGATOR",[73,77],{"name":70,"role":74,"phone":75,"phoneExt":36,"email":76},"CONTACT","91 9530199967","drniteshgonnade9@gmail.com",{"name":78,"role":74,"phone":79,"phoneExt":36,"email":80},"Shobhan B Varthya, MBBS, MD(Pharmacology)","91 8437726777","drshobanpgimer@gmail.com",[82],{"facility":5,"status":36,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Jodhpur","Rajasthan","342005","India","IN",{"type":89,"coordinates":90},"Point",[91,92],73.00594,26.26841,{"lat":92,"lon":91},[95,96,97,98,101,103,105,107,109,111,113,115,117,119],{"name":70,"role":74,"phone":75,"phoneExt":36,"email":76},{"name":78,"role":74,"phone":79,"phoneExt":36,"email":80},{"name":70,"role":71,"phone":36,"phoneExt":36,"email":36},{"name":99,"role":100,"phone":36,"phoneExt":36,"email":36},"Meenakshi Sharma, BAMS, MD(Ayurveda)","SUB_INVESTIGATOR",{"name":102,"role":100,"phone":36,"phoneExt":36,"email":36},"Purvi Purohit, PhD (medical) Biochemistry",{"name":104,"role":100,"phone":36,"phoneExt":36,"email":36},"Kamla K Shukla, Ph.D(Med Biochemistry) Postdoc",{"name":106,"role":100,"phone":36,"phoneExt":36,"email":36},"Om Lata Bhagat, MBBS, MPH, MD (Physiology)",{"name":108,"role":100,"phone":36,"phoneExt":36,"email":36},"Ravi Gaur, MBBS, MD(PMR), DNB(PMR), PGDHM",{"name":110,"role":100,"phone":36,"phoneExt":36,"email":36},"GyanPrakash Sharma, BAMS, MD (Ayurveda)",{"name":112,"role":100,"phone":36,"phoneExt":36,"email":36},"Purnandu Sharma, BAMS, MD (Yoga & Rehab)",{"name":114,"role":100,"phone":36,"phoneExt":36,"email":36},"Sandeep K Yadav, MBBS, MS (Orthopedics)",{"name":116,"role":100,"phone":36,"phoneExt":36,"email":36},"Prem P Sharma, PhD and MSc (Statistics), PSCC",{"name":118,"role":100,"phone":36,"phoneExt":36,"email":36},"Nitesh Gahlot, MS and DNB Ortho, MANMS, FACS",{"name":78,"role":100,"phone":36,"phoneExt":36,"email":36},{"type":71,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Nitesh Manohar Gonnade","Additional Professor",[124],{"name":125,"class":6},"Indian Council of Medical Research","100651946","holistic-healing-for-knee-osteoarthritis-100651946",false,"NCT07768709","Holistic Healing for Knee Osteoarthritis","Holistic Healing for Knee Osteoarthritis: Comparing Integrated, Standard Medical, and Ayurvedic Care","HEAL-KOA","Inclusion Criteria:\n\n* Age between 30 and 65 years, including males and females both\n* Diagnosis of primary osteoarthritis (OA) affecting at least one knee joint.\n* Kellgren-Lawrence (KL) grading of 1 or 2, indicating mild to moderate OA severity.\n* Baseline Numeric Rating Scale (NRS) score of ≥ 5 out of 10, indicating moderate to severe pain intensity.\n\nExclusion Criteria:\n\n* Secondary arthritis due to systemic inflammatory arthritis.\n* History of post-traumatic knee osteoarthritis.\n* Previous total knee replacement (TKR) surgery.\n* Recent corticosteroid use for knee-related conditions.\n* Prior intra-articular viscosupplementation treatment.\n* Allergy to allopathic and Ayurvedic medications used in the study.\n* Concomitant skin disease at the application site of any study intervention.\n* Uncontrolled diabetes mellitus\n* Chronic Renal failure\n* Pregnant and lactating females","ALL","30 Years","65 Years",{"count":138,"type":139},300,"ESTIMATED","INTERVENTIONAL",[142],"NA","This study is a single-center, three-arm, open-label randomized controlled trial designed to compare the effectiveness of integrated care, standard medical care, and Ayurvedic care in adults with early knee osteoarthritis (Kellgren-Lawrence grades I-II). Knee osteoarthritis is a leading cause of pain, functional limitation, and reduced quality of life, and current management often provides incomplete symptom relief. Although conventional medical and Ayurvedic interventions are widely used in clinical practice, comparative evidence evaluating these treatment approaches individually and in combination remains limited.\n\nA total of 300 participants aged 30-65 years with primary knee osteoarthritis will be randomly allocated in a 1:1:1 ratio to receive standard medical care, Ayurvedic care, or integrated care. The standard medical care group will receive oral paracetamol, topical diclofenac spray, transcutaneous electrical nerve stimulation (TENS), and superficial heat or cold therapy. The Ayurvedic care group will receive Trayodashang Guggulu, Ashwagandha Churna, Janubasti therapy, and topical application of Mahanarayana Taila. The integrated care group will receive Trayodashang Guggulu, Ashwagandha Churna, topical diclofenac spray, and portable transcutaneous electrical nerve stimulation (TENS). Participants will be followed for 24 weeks.\n\nPrimary outcome measures include changes in knee pain intensity, knee osteoarthritis symptoms, knee joint surface temperature, and gait kinematic parameters. Secondary outcome measures include changes in erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). The findings of this study are expected to provide evidence regarding the comparative effectiveness of integrated care, standard medical care, and Ayurvedic care in the management of early knee osteoarthritis.",[145],"Primary Knee Osteoarthritis (Kellgren-Lawrence Grade 1-2)",[147],"OA knee, Conventional standard care, Janubasti, Gait","NOT_YET_RECRUITING","2026-08-12",{"date":151,"type":152},"2026-08-17","ACTUAL",{"date":154,"type":139},"2026-09",{"date":156,"type":139},"2029-06",{"name":5,"class":6},1]