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Study of some herbal formulations in the management of Osteoarthritis Knee

Clinical evaluation of Yogaraj Guggulu, Gandharvahasta taila and Dhanwantara taila in the management of Osteoarthritis knee

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/01/006552
Enrollment
120
Registered
2016-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: null- Osteoarthritis Knee

Interventions

Intervention1: Yograj Guggulu Gandharvahasta taila Dhanwantara taila: Yograj Guggulu - 500 mg orally (crushed into powder) thrice a day with luke warm water after food for 12 weeks. Gandharvahasta tai

Sponsors

Cental Council for Research in Ayurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex aged between 35 and 65 years. 2. Patient of primary Osteoarthritis knee (Unilateral/ bilateral) as per at least three of following ACR clinical category of diagnostic criteria i.e.- i) crepitus on active motion, (ii) 3. Radio graphical changes as per Grade I to III of Kellgren & Lawrence Radiological scale. 4. Able and willing to participate and provide signed informed consent.

Exclusion criteria

Exclusion criteria: a. Patients with Grade IV Kellgren & Lawrence Radiological scale b. History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s). c. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis. d. Patients having any deformity of knee hip or back altering the gait and posture of the patient. e. Any unstable cardio-vascular diseases f. Patients with diabetes mellitus HbA1C > 6.5% g. Any other chronic systemic illness h. Patients with evidence of malignancy. i. History of knee arthroscopy/ knee replacement surgery j. Patients with concurrent hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT) > 2 times upper normal limit or Renal Disorders (defined as S. creatinine > upper limit of Lab. value), Pulmonary Dysfunction (Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]) k. The patient has been administered any chondoprotective drugs, intra-articular injection into the affected joint or systemic medication with corticosteroids during the preceding 3 months. l. Pregnant / lactating woman. m. Patient has an acute mental disorder n. Patients who are currently participating in any other clinical trial. Any other condition which the Principal Investigator thinks may jeopardize the study

Design outcomes

Primary

MeasureTime frame
Any changes in Western Ontario and McMaster University osteoarthritis (WOMAC) total scoreTimepoint: 4th, 8th, 12th week

Secondary

MeasureTime frame
â?¢ Assessment of changes in Ayurvedic disease specific symptoms of sandhi vata [Time frame: at baseline and end of the 12th week] â?¢ Assessment of changes in subjects of different Prakritis using a specific questionnaire. â?¢ Assessment Quality of life by using WHOQOL BREF questionnaire [Time frame: at baseline,12th and end of the 16th week] â?¢ Use of analgesic in comparison to baseline (No. of times use of conventional analgesic drug). [Time frame: at baseline and 12th week] Timepoint: â?¢ Assessment of changes in Ayurvedic disease specific symptoms of sandhi vata [Time frame: at baseline and end of the 12th week] â?¢ Assessment of changes in subjects of different Prakritis using a specific questionnaire. â?¢ Assessment Quality of life by using WHOQOL BREF questionnaire [Time frame: at baseline,12th and end of the 16th week] â?¢ Use of analgesic in comparison to baseline (No. of times use of conventional analgesic drug). [Time frame: at baseline and 12th week]

Countries

India

Contacts

Public ContactDr Subhash Singh

Ayurveda central Research Institute

subh9singh@gmail.com9650073350

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026