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CTRI Number  CTRI/2024/03/064681 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   role of ayurveda in the management 0f osteoarthritis 
Scientific Title of Study   Efficacy of Ushma Swedana and Upanaha Swedana in the Management of Janu Sandhigata Vata w.s.r. to Knee Osteoarthritis- An Open Labelled Randomized Comparative Clinical Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vanita C Gulwani 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Panchakarma, 4th floor, Institute of Teaching and Research in Ayurveda

Jamnagar
GUJARAT
361008
India 
Phone  9023570954  
Fax    
Email  vanitagulwani16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr Anup Thakar 
Designation  HOD 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Panchakarma, 4th floor, Institute of Teaching and Research in Ayurveda

Jamnagar
GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr Anup Thakar 
Designation  HOD 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Department of Panchakarma, 4th floor, Institute of Teaching and Research in Ayurveda


GUJARAT
361008
India 
Phone  9427776660  
Fax    
Email  anup_thakar@yahoo.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda, Jamnagar 361008 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda 
Address  Opposite B-Division Police Station, Gurudwara Road, Jamnagar-361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vanita C Gulwani  PG Hospital, Institute of Teaching and Research in Ayurveda  OPD 14, PG Hospital, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar
GUJARAT 
9023570954

vanitagulwani16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-UShmasvedaH, ऊष्मस्वेदः (Procedure Reference: Sushruta Samhita, Chikitsa sthana, Chapter 32, Verse, 5, Procedure details: Poorva Karma (Preparatory phase) - The patient should sit comfortably on a table and Abhyanga with suitable Taila will be done on the knee joint. Pradhan Karma (Treatment phase) - Ishtika will be heated red hot and then dipped in Kanji. It is then applied on the affected joint covered with wet cloth. Once when the Ishtika gets cooled down it will be replaced by another warm Ishtika. This will be carried out two times a day. Paschat Karma (Aftercare phase)- After the procedure, patient s)
(1) Medicine Name: Ishtika, Reference: Sushruta Samhita, Chikitsa sthana, Chapter 32, Verse, 5, Route: Topical, Dosage Form: Not Applicable, Dose: 50(NA), Frequency: bd, Duration: 14 Days
2Comparator ArmProcedure-upanAhasvedaH (sAgniH, उपनाहस्वेदः (साग्निः) (Procedure Reference: ushruta Samhita, Chikitsa sthana, Chapter 32, Verse, 3, Procedure details: Poorva Karma (Preparatory phase) - The patient should sit comfortably on a table and Abhyanga with suitable Taila will be done on the knee joint. Pradhan Karma (Treatment phase) – Eranda Taila will be heated in a frying pan. Kolakulatthadi Upnaha Dravya will be added and heated for a suitable time. Kanji will be added and the drug will be made into a paste form. Eranda Patra smeared with Eranda Taila will be heated on both sides and the above Upnaha Dravya will be made in a flat paste o)
(1) Medicine Name: Kolakutthadi Upanaha, Reference: Charak Samhita, Sutrasthana Chapter 2, Verse 18, Route: Topical, Dosage Form: Lepa Churna, Dose: 100(g), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients presenting with the classical signs and symptoms of Janu Sandhigata Vata (OA) like Sandhishotha, Akunchan prassarne vedana, Knee joint pain, Tenderness at the knee joint, Knee joint Crepitus and Stiffness at the knee joint.
X-ray changes in Knee Joint: Grade 1, 2 and 3
Patients of either sex age between 30 - 70 years will be included.
Patients suitable for Swedana Karma. 
 
ExclusionCriteria 
Details  Patients below 30 years and above 70 years of age.
Patients not suitable for Swedana Karma.
Patients suffering from Gout, Rheumatoid arthritis, Systemic Lupus Erythematous (SLE), Bone TB, Psoriatic arthritis, Effusion, Sever reduction of knee and other serious systemic disorders.
X-ray changes in Knee Joint: Grade 4.
Patient with skin diseases on knee joints. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients may show reduction of Pain, stiffness, reduction in swelling, reduction of tenderness and improved range of motion.  14 days for Group A and Group B 
 
Secondary Outcome  
Outcome  TimePoints 
Xray Changes  14 days for both groups 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 23/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Introduction:

Sweda means sweat and the therapy in which the perspiration is produced is known as Swedana. In Ayurveda, different types of Swedana procedures are described based on the methods of transferring the heat energy as per the Dosha condition. Swedana Karma is mainly indicated for Vata and Kapha dosha conditions. Different varieties of Swedana have been described in various texts. Out of which four types of Swedana have been described by Acharya Sushruta and Acharya Vagbhatta. Here, Ushma and Upanaha Swedana are selected amongst the four types of Swedana described by Acharya Sushruta and Vagbhata. Varied indications are mentioned for the use of different types of Swedana Karma. Amongst them the most common condition found in daily practice is Sandhigata Vata.

 Significance:

Swedana Karma has four major actions over body. Stambhaghna, Gauravaghna, Sheetaghnata, Swedakarakta. In Knee osteoarthritis, it is found that there is pain of the joint followed by spasm of Hamstring muscles, deformity of Tibia and Valgus deformity. There is swelling around the joint along with Quadriceps atrophy. It is generally managed by Analgesics, Steriods orally or injected locally, supplements, etc. for a long duration. In order to relieve the stress caused on the joint, a safe and reliable treatment in the form of Swedana Karma were selected. Acharya Sushruta has also mentioned Snehana, Upanaha, Agni Karma, Bandhana and Mardana as the treatment of Sandhigata Vata. Thus, taking these principles into consideration 2 methods of Swedana i.e. Ushma Swedana and Upanaha Swedana were selected for the present study.

Aim & Objectives:

Evaluation and Comparison of the efficacy of Ushma Swedana and Upanaha Swedana in the management of Janusandhigata Vata w.s.r. Knee Osteoarthritis.

Materials and Methods:

30 Diagnosed and newly diagnosed Patients of Janusandhigata Vata (Knee Osteoarthritis) will be enrolled in two groups. Group A patients received intervention with Ishtika Ushma Swedana Karma and Group B patients received Upanaha Swedana with Kolakulatthadi Churna.

Results and Discussion:

Statistically Highly significant results were seen in both the groups in the subjective and objective parameters. Whereas on comparison insignificant results were seen between groups. Both the procedures proved effective in management of Knee OA as the temperature change of the substance and knee joint lead to pacification of both the Doshas. Therefore improvement in symptoms was seen. 

Follow up:

After completion of therapy, follow up was done after 15 days to assess the status of patient.

Adverse effects:

No adverse reaction of drug or procedure was seen during entire study period. 

Conclusion:

Hence Null hypothesis was accepted and Alternate hypothesis were rejected.

 
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