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Clinical Trials/CTRI/2024/08/072826
CTRI/2024/08/072826
Not yet recruiting
Phase 3

A Randomized Controlled Clinical Trial to evluate the effect of Tryushanadi Gutika in the management of Janu Sandhigata Vata ( Knee Osteoarthritis)

Dr J Gayathri1 site in 1 country30 target enrollmentStarted: August 21, 2024Last updated:

Overview

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Dr J Gayathri
Enrollment
30
Locations
1
Primary Endpoint
Reduction in Bony tenderness, Bony enlargement, Pain in the knees.

Overview

Brief Summary

Knee Osteoarthritis is the most common type of arthritis which ranked as 4th largest contributor to global disability. Risk factors for developing OA include age, gender, obesity, anatomical abnormalities, muscle weakness, and joint injury (occupation/sports activities). Globally, 595 million people had osteoarthritis in 2020, and there is an increase of 132.2% in total cases since 19903 . Compared with 2020, it is estimated that by 2050 there will be a drastic increase in the number of cases of osteoarthritis by 74.9% in knee joint, 48.6% in hand, 78.6% in Hip, 20.4% with High BMI, 44% in Post Menopausal females . A study conducted in 2019 shows that 62.35 million people have got affected with osteoarthritis in India  . In 2023, Prevalence of knee osteoarthritis in India was 73.41% in Females and 26.58% in males . In Kancheepuram, Tamilnadu a study conducted in 2022 states that there was 29.8% prevalence in females and 22.3%in males. According to WHO, it is said that by 2021-2030 osteoarthritis will be the major cause of adult disability. Tryushnadi gutika containing Shunti, Maricha, Pippali, Pippalimula, Chitraka, Haridra, Daruharidra, Ajamoda, Yavani, Pathya, Suvarchala, Saindhava, Bakuchibija, Yavakshara, Vidanga, Vacha, Guggulu is indicated in Sandhyasthimajjagata vata. This formulation has tikta, katu rasa, laghu snigdha guna, Ushna virya, Katu vipaka and vatakapha hara in nature. Haritaki which has analgesic activity is used in chronic pain management especially in geriatric patients . This gutika increases the Dhatwagni and removes the excess Kapha obstructing the srotas. Guggulu & Haritaki has Rasayana properties. Also guggulu is considered to have anti-arthritic activity. Hence, Tryushanadi Gutika has been selected as a Trial drug. Trayodashanga Guggulu has Abha, Ashwagandha, Rasna etc. which is Ushna virya with Laghu, Snigdha and Vatahara property. It also has anti-inflammatory and analgesic effects. A Clinical Study by Gandagi Nagesh and Patil Shubhangi (2016) Ahalia Ayurveda Medical College & Hospital, Palakkad, Kerala has statistically proven (p<0.001) the efficacy of Tryodashanga Guggulu in Janu sandhigata vata (Knee osteoarthritis). Hence it has been taken as the control drug. In Contemporary science, NSAIDs, corticosteroids, intra articular hyaluronic injection modalities are used for the treatment of osteoarthritis, which relieve the symptoms temporarily but is incapable of providing a permanent cure. In later stages, surgeries are carried out to replace knee joints. To combat these, effective treatments are needed. Hence, on these considerations I have made a humble attempt on the study entitled: “A Randomized Controlled clinical trial to evaluate the effect of Tryushanadi Gutika in the management of Janu Sandhigata Vata (Knee Osteoarthritis).”

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects between 40 to 70 years of age of either sex.
  • patients suffering from bony enlargement, bony tenderness with no palpable warmth
  • patients diagnosed with Knee osteoarthritis as per ACR Criteria 4.

Exclusion Criteria

  • Grade 3 and grade 4 radiographic changes
  • History of knee replacement surgery
  • History of prior intra-articular corticosteroid administration or Hyaluronic acid administration.

Outcomes

Primary Outcomes

Reduction in Bony tenderness, Bony enlargement, Pain in the knees.

Time Frame: 30 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr J Gayathri
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr J Gayathri

Sri Jayendra Saraswathi Ayurveda College and Hospital

Study Sites (1)

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