| CTRI Number |
CTRI/2025/03/082022 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know the efficacy of black mustard seeds in the management of Amavata (Rheumatoid Arthritis). |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Sarshapa Pottali Sweda In The Management Of Amavata (Rheumatoid Arthritis) |
| 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 Shradha H |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room 20 Second Floor Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
Tamilnadu India.
600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9841208321 |
| Fax |
|
| Email |
dr.shradha.ayupanchakarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitta Ranjan Das |
| Designation |
Principal Head of Department and Professor |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room 20 Second Floor Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
Tamilnadu India
600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9444123506 |
| Fax |
|
| Email |
drcrdayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shradha H |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
| Address |
Room 20 Second Floor Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Nazarathpet Chennai
Thiruvallur
Tamilnadu India
600123
Thiruvallur
TAMIL NADU
600123
India |
| Phone |
9841208321 |
| Fax |
|
| Email |
dr.shradha.ayupanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 20 Second floor Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital Chennai 600123 |
|
|
Primary Sponsor
|
| Name |
Dr Shradha H |
| Address |
Room no 20 Second floor Department of Panchakarma Sri Jayendra Saraswathi Ayurveda College and Hospital 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 Shradha H |
Sri Jayendra Saraswathi Ayurveda College and Hospital |
Room no 20 Second floor Department of Panchakarma
Sri Jayendra Saraswathi Ayurveda College and Hospital
Nazarathpet Chennai 600123
Thiruvallur
TAMIL NADU |
9841208321
dr.shradha.ayupanchakarma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital, SCSVMV, Nazarathpet, Chennai. 600123. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Yogaratnakara, Procedure details: Sarshapa is tied in a pottali. this pottali is heated and applied over patients body.)
(1) Medicine Name: Amavatari ras, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | svedanam, स्वेदनम् | (Procedure Reference: Yogaratnakara, Procedure details: Sand is tied in apottali and heated, applied over patients body.)
(1) Medicine Name: Amavatari ras, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as amavata , signs and symptoms mentioned in ayurvedic classics.
2. Morning stiffness for more than an hour.
3. Anti CCP positive and serum uric acid is negative. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe degree of deformity
2. patients with major complications.
3. gouty arthritis.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce the signs and symptoms of amavata and assessment of pain and inflammation in the effected joints using CDAI index. |
37 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/03/2025 |
| 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 Yet Recruiting |
| 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
|
Rheumatoid arthritis is an autoimmune disease that has increased prevalence in India . The prevalence of rheumatoid arthritis in a 2023 study concludes that 0.46% is the global average rate while in India its 0.75%. it is characterized by stiffness and pain in the joints , especially in the mornings, termed as morning stiffness. amavata is a disease caused due to improperly digested metabolites, that gets propelled and settle in the joints causing pain stiffness ,swelling , loss of appetite and fatigue. due to the similarity in presentation of the illness , parallels can be drawn between amavata and rheumatoid arthritis. swedana procedure brings about perspiration , reduction of stiffness and pain . Among which valuka sweda , is proven to be highly effiective in the treatment of amavata. sarshapa being praised for its penetrative nature, ushnatha , vranaghna ,amavatahara nature. Pottali sweda using sarshapa black mustard, in comparison to valuka sweda.. An attempt is made to understand and evaluate the efficacy of sarshapa pottali sweda in the management of rheumatoid arthritis. Amavatari rasa is a potent internal medicine specific to amavata , mentioned by bhaishajya ratnavali . It is given as an internal medication in this study. |