| CTRI Number |
CTRI/2025/04/085325 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| 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
|
Use Of Karpaskulatthikadi Pottali Sweda In Amavata |
|
Scientific Title of Study
|
An Open Randomized Controlled Clinical Trial Of Karpaskulatthikadi Pottali Sweda In Amavata With Special Reference To 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 Anagha Sanjay Patil |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Department Of Panchakarma
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta 416301, Sangli Maharashtra, India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
8975899937 |
| Fax |
|
| Email |
anagha.patil15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar Mane |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Department Of Panchakarma
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta 416301, Sangli Maharashtra, India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
9922454406 |
| Fax |
|
| Email |
shnkrmane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar Mane |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
Department Of Panchakarma
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta 416301, Sangli Maharashtra, India.
Sangli
MAHARASHTRA
416301
India |
| Phone |
9922454406 |
| Fax |
|
| Email |
shnkrmane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta Tal Walwa Dist Sangli Maharashtra 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Anagha Sanjay Patil |
| Address |
OPD no 9 , Panchakarma OPD , Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta 416301 , Tal-Walwa, Dist-Sangli , Maharashtra, Inia. |
| 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 Anagha Sanjay Patil |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center, Ashta |
Department Of Panchakarma, OPD/IPD Of panchakarma, Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center, Ashta
Sangli
MAHARASHTRA |
8975899937
anagha.patil15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee OfHon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center, Ashta |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sa~gkarasvedaH, संकरस्वेदः | (Procedure Reference: Charak Samhita, Sutrasthan, Procedure details: Sankar svedana will given OD for 7 days )
(1) Medicine Name: karpasbeejadi cjurna, kanji, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 200(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | sa~gkarasvedaH, संकरस्वेदः | (Procedure Reference: Charak Samhita Sutrasthan, Procedure details: Sankar svedana will be given OD for 7 days)
(1) Medicine Name: valuka, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 200(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having the signs and symptoms of Amavata; Sandhishool, Sandhishoth, Sparshasahtva, Sandhi Stabhata, Jwara
2. Patient will be selected irrespective of gender, occupation, and habitat, religion.
3. Patient fit for Pottali Sweda.
4. Chronicity less than 5 yrs.
5. First and second stage of Rheumatoid Arthritis |
|
| ExclusionCriteria |
| Details |
1. Third and Fourth stage of Rheumatoid Arthritis 2. Juvenile Rheumatoid Arthritis
3. Skin diseases, Infectious disease like Osteomyelitis, tuberculosis, Malignancy.
4. Any surgical condition such as Patient with trauma or Accident, fracture, any open wound.
5. Patients with Sandhi Vakrata.
6. Pregnant women, lactating mothers
7. Steroid dependent.
8. Patients is on NSAID. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Karpaskulstthikadi Pottali Sweda Is Effective In The Management Of Amavata |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Valuka Pottali Sweda Is Effective In The Management Of Amavata |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/05/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
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)
|
Rheumatoid Arthritis is a chronic autoimmune disease that causes inflammation and it primarily affects joints, leading to disability and reduced quality of life. It is more prevalent in women, with a global prevalence ranging from 0.3 – 2.1% . It is a genetic disorder. Rheumatoid Arthritis causes inflammation with Sign symptoms including pain, swelling, tenderness of joints, joint stiffness, fatigue, fever, loss of appetite. Above mentioned sign and symptoms of Rheumatoid Arthritis can be correlated with Amavata. In Ayurveda, Amavata first explained in Madhavnidana by Madhavkara. He also explained that samprapti of almost all diseases begin with the agnimandya which leads to formation of Ama, this ama is a most important causative factor for various diseases . Amavata is a disease in which vitiation of Vata Dosha and accumulation of Ama take place in joints. Whenever that Ama gets localized in the body tissue or joints, it can lead to production of pain, stiffness, swelling, tenderness in the related joints. It is the disease of Madhyam rogamarg Asthi and Sandhi are the chief site for the manifestation of cardinal symptoms like Angmard, Sandhishool, Shandhishoth and Sandhigraha. Bhaishajya Ratnavali has explained chikitsa of Amavata in detail including its specific line of treatment like Langhana, Swedana, Deepana, Pachana, Snehpana, Virechana and Basti from above, Swedana, Snehapana, Virechana, Basti are Panchakarma procedures which are traditional ayurvedic treatment that plays a crucial role in managing Aamvata. In Ayurvedic treatment principles for Amavata involve therapeutic methods like Swedana. Here Karpaskulatthikadi Pottali Sweda include karpasthi, kulattha, til, yava, erandamula, Atasi, varshabhu, shanabeej, kanji after making Pottali, Sweda will be given to sarvang for 7 days. So, it will help in reduction of samavata which ultimately reduces stiffness, pain, swelling of joints. Also, it is affordable, easy for administration. |