| CTRI Number |
CTRI/2025/10/096459 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
26/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of sarvanga tvagadi alepa in the management of amavata w.s.r to rheumatoid arthritis |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the effect of sarvanga tvagadi alepa in the management of amavata w.s.r 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 |
Sushmitha K |
| Designation |
Pg Scholar |
| Affiliation |
shri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady udupi |
| Address |
OPD-9 department of panchakarma shri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8921691070 |
| Fax |
|
| Email |
sushmithakgg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Padmakiran C |
| Designation |
BAMS MD(AYU) Ph.D Professor department of panchakarma |
| Affiliation |
shri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady udupi |
| Address |
OPD-9 Department of panchakarma shri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448953038 |
| Fax |
|
| Email |
kiranasdm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Padmakiran C |
| Designation |
BAMS MD(AYU) Ph.D PROFESSOR DEPARTMENT OF PANCHAKARMA |
| Affiliation |
shri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady udupi |
| Address |
OPD-9 department of panchakarma shri dharmasthala manjunatheshwara college of ayurveda hospital and research centre kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448953038 |
| Fax |
|
| Email |
kiranasdm@gmail.com |
|
|
Source of Monetary or Material Support
|
| shri dharmasthala manjunatheshwara ayurveda pharmacy Kuthpady Udupi karnataka india-574118 |
|
|
Primary Sponsor
|
| Name |
Sushmitha K |
| Address |
Nethravathi ladies hostel near Sdm college of Ayurveda Kuthpady Udupi 574118 |
| 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 Sushmitha K |
Shri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research centre kuthpady Udupi |
OPD-9 department of panchakarma udupi karnataka
Udupi
KARNATAKA |
8921691070
sushmithakgg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College of Ayurveda Udupi Institutional Ethical clearance committee-humans |
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 | Drug | Other than Classical | | (1) Medicine Name: sarvanga tvagadi alepa, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 400(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | agni chikitsa alepa | Agnichikitsa alepa: Lashuna – 8 beads, Lavanga – 8 in number, Maricha – 8 seeds, Sarshapa – 5gm, Haridra – 5gm these are the 5 dry drugs and wet drugs are Vanatulasi, Kshudra agnimantha, Nirgundi, Papata, Bandha. Leaves of these wet drugs taken in equal quantity sufficient enough to prepare a paste to apply all over the body of the patient. These leaves should be washed and the thick mid veins present in the leaves should be removed and chopped into small pieces. Then dry drugs and wet drugs are mixed together and grinded into a smooth semisolid paste by adding required quantity of water. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling diagnostic criteria.
Patients who are fit for Alepa chikitsa.
|
|
| ExclusionCriteria |
| Details |
All connective tissue disorders other than Rheumatoid arthritis.
Patients with any other systemic illness which will hamper treatment.
All patients who are allergic to alepa.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parametric data analysed before and after the study using paired t test for within the group and unpaired t test for between the group.
Non parametric data analysed before and after the study using Wilcoxon signed rank test for within the group and Mann Whitney test for between the group.
The signs and symptoms will be assessed before treatment on 0th day and after the treatment on 7th day and after 14 days of follow up based on subjective and objective parameters. |
14 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
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
• This is an open label comparative clinical study with pre-test and post-test design where minimum 30 patients of Amavata of either gender will be selected based on diagnostic and inclusion criteria and randomly distributed between Agnichikitsa alepa and Sarvanga Tvagadi alepa group. |