A clinical trail to compare and study the effect of Panchatikta Ghruta Guggulu in the Management of Osteoarthritis in Postmenopausal Women

Efficacy of Panchatikta Ghruta Guggulu in the Management of Osteoarthritis in Postmenopausal Women -A Randomized controlled Trial - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/071761

Enrollment

104

Registered

2024-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: M17- Osteoarthritis of knee Health Condition 3: M171- Unilateral primary osteoarthritisof knee

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects aged between 40 - 60 years. 2.Patients with classical presentations of Sandhigata vata and rajonivrutta stri will be selected irrespective of their religion and occupation. 3.Subjects fulfilling the diagnostic criteria & diagnosed previously (As per American college of Rheumatology (ACR) classification criteria for OA of the Knee). 4.Affected knee joint - Single or Both 5.Subject who submit a written informed consent. 6.One month after the completion of participation in any other clinical trial

Exclusion criteria

Exclusion criteria: 1.Severe arthritis1.(KL grade IV) 2.Patients with RA, Gout, Osteoporosis and other musculoskeletal system disorders 3.Known cases of secondary OA due to tuberculosis (TB), syphilis, aids and leprosy 4.Gross disability like bedridden and confined to wheel chair 5.Patients with other major systematic disorders which interfere with the treatment will be excluded like uncontrolled DM 6.Patients with .Significant knee injury within past 6 months; presence of a rash or open 6.wound over the knee. 7.Use of NSAID’s, Analgesics, Intra articular steroid injections within the past period of 30 days 8.Patients with history of knee surgery or arthroscopy within the past year; knee replacement on study knee 9.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.

Design outcomes

Primary

Measure	Time frame
Changes in Janu sandhi shoola (Knee osteoarthritic pain) i.e WOMAC28 (Western Ontario and Mc-Master University Osteoarthritis Index) and VAS29 ScaleTimepoint: baseline and at 30th ,60th days	—

Secondary

Measure	Time frame
–Changes on walking speed –Changes in Serum Calcium & alkaline phosphatase –Changes in inflammatory markers (IL 6 & TNF alpha) –Changes in Range of Motion : Goniometric assessment –Changes in Quality of Life (QoL): Short Form-36Timepoint: –from baseline & at 30th ,60th days – from baseline & in 60 days –from baseline & in 60th days –at baseline & at 30th, 60th days – at baseline & at 30th, 60th days	—

Measure

Time frame

–Changes on walking speed –Changes in Serum Calcium & alkaline phosphatase –Changes in inflammatory markers (IL 6 & TNF alpha) –Changes in Range of Motion : Goniometric assessment –Changes in Quality of Life (QoL): Short Form-36Timepoint: –from baseline & at 30th ,60th days – from baseline & in 60 days –from baseline & in 60th days –at baseline & at 30th, 60th days – at baseline & at 30th, 60th days

—

Countries

India

Contacts

Public ContactDr Basavaraj Tubaki

KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi

ayurbasavaraj@gmail.com9448634660

Outcome results