| CTRI Number |
CTRI/2024/08/072826 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Tryushanadi Gutika in Knee Osteoarthritis |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to evluate the effect of Tryushanadi Gutika in the management of Janu Sandhigata Vata ( Knee Osteoarthritis) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Gayathri |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17
Department of Kayachikitsa
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Chennai 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9080451136 |
| Fax |
|
| Email |
shreeharigayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Kumar Moharana |
| Designation |
Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17
department of Kayachikitsa
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Chennai 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444123608 |
| Fax |
|
| Email |
pkm_ayur@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Gayathri |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room no 17
Department of Kayachikitsa
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Chennai 600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9080451136 |
| Fax |
|
| Email |
shreeharigayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai 600123 |
|
|
Primary Sponsor
|
| Name |
Dr J Gayathri |
| Address |
Room no 17
Department of Kayachikitsa
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet
Chennai 600123 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr J Gayathri |
Sri jayendra Saraswathi Ayurveda College and Hospital |
Room no 17 Department of Kayachikitsa
Chennai Bangalore highway
Chennai
600123
Thiruvallur
TAMIL NADU |
9080451136
shreeharigayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee , Sri Jayendra Saraswathi Ayurveda College and Hospital, Department of Ayurveda of SCSVMV, Nazarathpet, Chennai 600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M15-M19||Osteoarthritis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga Guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tryushanadi Gutika, Reference: Rasa Ratnakara , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects between 40 to 70 years of age of either sex.
2. patients suffering from bony enlargement, bony tenderness with no palpable warmth
3. patients diagnosed with Knee osteoarthritis as per ACR Criteria
4. Grade 1 and Grade 2 radiographic changes as per KL Classification |
|
| ExclusionCriteria |
| Details |
1. Grade 3 and grade 4 radiographic changes
2. History of knee replacement surgery
3. History of prior intra-articular corticosteroid administration or Hyaluronic acid administration.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Bony tenderness, Bony enlargement, Pain in the knees. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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).†|