| CTRI Number |
CTRI/2023/10/058901 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Madayantivaatari taila in knee joint pain |
|
Scientific Title of Study
|
A Comprehensive (Pharmaceuitical, Analytical and Clinical)study of Madayantivaatari taila in Sandhivata(Osteoarthritis) |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preeti Tamta |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Rasa-Shastra Evam Bhaishjya kalpana Institute of Medical Sciences Banaras Hindu university
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8755203735 |
| Fax |
|
| Email |
tamtapreeti03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anand Kumar Chuadhary |
| Designation |
prof |
| Affiliation |
Banaras Hindu University |
| Address |
Rasa-Shastra Evam Bhaishjya kalpana Institute of Medical Sciences Banaras Hindu university
Rasa-Shastra Evam Bhaishjya kalpana Institute of Medical Sciences Banaras Hindu university
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9305471508 |
| Fax |
|
| Email |
anandayubhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Tamta |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Rasa-Shastra Evam Bhaishjya kalpana Institute of Medical Sciences Banaras Hindu university
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8755203735 |
| Fax |
|
| Email |
tamtapreeti03@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Preeti Tamta |
| Address |
Rasa shastra evaum bhaisjya kalpana Institute of medical sciences banaras hindu university |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Preeti Tamta |
Sir sunderlal hospital, Banaras Hindu University |
Department of Rasashastra and Bhaisjyakalpana
/opd no-11 B
Varanasi
UTTAR PRADESH |
8755203735
tamtapreeti03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Panchavartita Madayantika vatari taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Murchita Madayantika Vatari taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Amurchita Madayanti Vatari taila, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Pain area-In the joint,hand ,hip, knee, lower back or neck
• Patient without any Anatomical deformity.
• Pain
• Stiffness
• Tenderness
• Loss of Flexibility
• Grating sensation
• Swelling |
|
| ExclusionCriteria |
| Details |
1-Patients not full filling the inclusion criteria.
2-Patients of age less than 40 and more than 80 years.
3-Patient with secondary osteoarthritis , Rheumatoid arthritis , Gouty arthritis.
4-Patient with a recent history of Any Trauma on knee joint.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain at affected joints,improvement in movement,stiffness and swelling at affected joints |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in score of VAS scale of pain , Increase in range of improvement of affected joints measured by goniometer, crepitus will be reduced or stop after using this taila |
2 month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| 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="0"
Months="5"
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
|
Osteoarthritis is by far the most common form of arthritis and is a major cause of pain and disability in older people and is characterized by focal loss of articular cartilage, subchondral osteosclerosis, osteophyte formation at the joint margin, and remodeling of joint contour with enlargement of affected joints. OA affects over 32.5 million US adults.Investigators found that globally, prevalent cases of osteoarthritis increased by 113.25 percent from 247.51 million in 1990 to 527.81 million in 2019. Osteoarthritis (OA) is the most prevalent chronic joint disease and remains one of the few chronic disorders of ageing for which there is little effective treatment and none proven that delays disease progression. It can affect small, medium, and large joints though, in terms of a painful disease, the knee is the most frequently affected with up to one in eight men and women over the age of 60 years having evidence of symptomatic knee OA. OA is a leading cause of disability in older adults and is one of the leading causes of impairment of mobility in the elderly population in the USA. It accounts also for substantial direct healthcare costs related largely to the requirement for joint replacement surgery in those with end-stage disease. Sandhigata Vata /Sandhivata has been told by Acharya Charaka in the chapter of “Vatavyadhi Chitiksaâ€. Its features resemble osteoarthritis as per Modern science. It means a condition in which morbid Vata gets located in joints and hinders the functioning of joints. The vitiated Vata on getting lodged in the joints of the body causes Sandhigata Vata. वातपूरà¥à¤£à¤¦à¥ƒà¤¤à¤¿à¤¸à¥à¤ªà¤°à¥à¤¶à¤ƒ शोथः सनà¥à¤§à¤¿à¤—तेऽनिले|
पà¥à¤°à¤¸à¤¾à¤°à¤£à¤¾à¤•à¥à¤žà¥à¤šà¤¨à¤¯à¥‹à¤ƒ पà¥à¤°à¤µà¥ƒà¤¤à¥à¤¤à¤¿à¤¶à¥à¤š सवेदना|| (च.चि २८/३7) The symptoms explained by Acharya Charaka are as follows- · Vatapurna - Pain · Vatapurna Driti Sparsha- sounds resembling that made when we rub against a transparent container filled with air. · Shotha - Swelling · Prasarana akunchanayoho pravritti- including painful extension and flexion.
|