Study of Ayurveda interventions for chronic knee pain in elderly

Evaluation of comparative efficacy of Ashwagandha versus Shallaki in chronic knee pain among older adults with knee osteoarthritis A double-blind randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088610

Enrollment

Registered

2025-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Participants having pain in one or both knee joints since more than three months Average severity of knee pain in the past week is reported more than four when assessed through Wong-Baker Faces Participants scoring more than three in the Mini-Cog scale Diagnosed cases of Knee osteoarthritis (OA) or those who fulfil the clinical American College of Rheumatology (ACR) criteria for knee osteoarthritis Able to give written informed consent

Exclusion criteria

Exclusion criteria: Non-ambulatory patients Participants showing severe osteoarthritis on radiological evaluation and eligible to be categorized as Grade-4 of Kellgren and Lawrence scale for OA (Antero-posterior X-Ray of the affected knee showing large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends) History of treatment with intra-articular injection of corticosteroids or hyaluronic acid or oral corticosteroids within a period of three months preceding study Patients on regular intake of Ayurveda medicines (including any Ayurveda procedures) or physiotherapy (including therapeutic exercises) for pain relief in the past 2 weeks Patients having unilateral/bilateral fixed flexion deformity in knees or metallic implant in knee joint; or severe deformity of lower limbs (e.g., knee varus or knee valgus) History of knee joint replacement

Design outcomes

Primary

Measure	Time frame
Change in score of Numeric Pain Rating ScaleTimepoint: Baseline; at the end of Week 2, Week 4 and Week 6	—

Secondary

Measure	Time frame
KOOS range of motion of the affected knee joint(s) TUG FTSST Wellbeing Index GSAQ Comparison of frequency of use of conventional analgesic medicines as rescue medication for symptomatic relief in knee pain during the study period, with baseline and between the groups Comparison of incidence of treatment emergent adverse events (like skin irritation, weight gain, gastric reactions, changes in vitals like blood pressure etc.) in both groupsTimepoint: Baseline and at the end of six weeks	—

Measure

Time frame

KOOS range of motion of the affected knee joint(s) TUG FTSST Wellbeing Index GSAQ Comparison of frequency of use of conventional analgesic medicines as rescue medication for symptomatic relief in knee pain during the study period, with baseline and between the groups Comparison of incidence of treatment emergent adverse events (like skin irritation, weight gain, gastric reactions, changes in vitals like blood pressure etc.) in both groupsTimepoint: Baseline and at the end of six weeks

—

Countries

India

Contacts

Public ContactDr Bharti

MGAC, DMIMS

Vkuchewar@gmail.com9420998747

Outcome results