| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | UShmasvedaH, ऊषà¥à¤®à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (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 | | 2 | Comparator Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहसà¥à¤µà¥‡à¤¦à¤ƒÂ (सागà¥à¤¨à¤¿à¤ƒ) | (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. |