| CTRI Number |
CTRI/2026/03/106251 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| 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
|
COMPARING SHOBHANJANA TWAK QWATHA AND DHANYAMLA PARISHEKA FOR TREATING RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
A Randomized Clinical Study To Evaluate The Efficacy Of Shobhanjana Twak Qwatha (Moringa oleifera Lam) Parisheka On Inflammatory Markers In The Management Of Amavata with special reference To Rheumatoid Arthritis |
| Trial Acronym |
STQP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHREYA TALWAI |
| Designation |
PG SCHOLAR |
| Affiliation |
SDM COLLEGE OF AYURVEDA, HOSPITAL AND RESEARCH CENTER, UDUPI |
| Address |
Department Of PG Studies In Panchakarma
Sri Dharmasthala Manjunatheshwara College Of Ayurveda, Hospital and Research Center, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9606699871 |
| Fax |
|
| Email |
talwaishreya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANJUNATH KANTHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SDM COLLEGE OF AYURVEDA, HOSPITAL AND RESEARCH CENTER, UDUPI |
| Address |
Department Of PG Studies In Panchakarma
Sri Dharmasthala Manjunatheshwara College Of Ayurveda, Hospital and Research Center, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9844469138 |
| Fax |
|
| Email |
kanthipk03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANJUNATH KANTHI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SDM COLLEGE OF AYURVEDA, HOSPITAL AND RESEARCH CENTER, UDUPI |
| Address |
Department Of PG Studies In Panchakarma
Sri Dharmasthala Manjunatheshwara College Of Ayurveda, Hospital and Research Center, Kuthpady, Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9844469138 |
| Fax |
|
| Email |
kanthipk03@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College Of Ayurveda, Hospital and Research Center Kuthpady Udupi Pin Code 574118 |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER |
| Address |
SDM College Of Ayurveda, Hospital and Research Center Kuthpady Udupi Pin Code 574118 |
| Type of Sponsor |
Private medical college |
|
|
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 SHREYA TALWAI |
SDM AYURVEDA HOSPITAL, UDUPI |
Panchakarma OPD NO 9, Department Of Panchakarma, SDM College Of Ayurveda, Hospital and Research Center Kuthpady Udupi Pin Code 574118
Udupi
KARNATAKA |
9606699871
talwaishreya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SDM COLLEGE OF AYURVEDA, UDUPI |
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 | - | pariSheka, परिषेक | (Procedure Reference: CHARAKA SAMHITA SUTRA STHANA 14/44, Procedure details: Purva Karma: Parisheka is done without Abhyanaga. The subject will be advised to lie down in supine position after passing the natural urges. Patient will be asked to lie down in supine position on the Droni/table.
Pradhana Karma: Parisheka qwatha will be gently poured from height of 9 inches from the surface of the patients body in supine and prone position. The temperature of the qwatha will be maintained between 38-42 degrees Celcius. Parisheka will be done for 30 minutes.
Paschat Karma: After the Pradhana karma, the body is wiped with soft cloth. Patient will be advised to rest and bath with luke warm water.)
(1) Medicine Name: SHOBHANJANA TWAK, Reference: CHARAKA SAMHITA SUTRA STHANA 4/13, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 5000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: CHARAKA SAMHITA SUTRA STHANA 14/44, Procedure details: PURVA KARMA: Parisheka is done without Abhyanaga. The subject will be advised to lie down in supine position after passing the natural urges. Patient will be asked to lie down in supine position on the Droni/table.
PRADHANA KARMA: Parisheka qwatha will be gently poured from height of 9 inches from the surface of the patients body in supine and prone position. The temperature of the qwatha will be maintained between 38-42 degrees Celcius. Parisheka will be done for 30 minutes.
PASHCHAT KARMA: After the Pradhana karma, the body is wiped with soft cloth. Patient will be advised to rest and bath with luke warm water.)
(1) Medicine Name: DHANYAMLA, Reference: SAHASRAYOGAM, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 5000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients confirmed with Positive Anti CCP test.
Patients presenting with sandhi shotha (swelling of joints), sandhi shola(joints pain), and any of two samanya lakshanas of Amavata i.e, angamardha (bodyache), aruchi (anorexia), trushna (thirst), alasya (lack of enthusiasm), gourava (heaviness), jwara (fever), apaka (indigestion)
patients fit for parisheka sweda. |
|
| ExclusionCriteria |
| Details |
Patinets with other systemic illness like uncontrolled diabetes mellitus and hypertension etc
All connective tissue disorder other than Rheumatoid arthritis.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the effect of Shobhanjana Twak Qwatha Parisheka and Dhanyamla Parisheka on inflammatory markers in the Amavata w.s.r. to Rheumatoid Arthritis. |
Before treatment 0th day, after treatment 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life. |
Before treatment 0th day, after treatment 7th day |
|
|
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)
|
01/04/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study titled A RANDOMIZED CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHOBHANJANA TWAK QWATHA (Moringa oleifera Lam) PARISHEKA ON INFLAMMATORY MARKERS IN THE MANAGEMENT OF AMAVATA W.S.R. TO RHEUMATOID ARTHRITIS - where Amavata is an Amaja Vyadhi that involves ama along with tridosha, if left untreate, will affect the dhatus. When aahara rasa does not underwent ahara-paka, it gets accumulated which is called Ama. Due to this Vata prakopa takes place, and then ama and vitiated vata, enter the joints and resulting stiffness in the body. The signs and symptoms can be correlated with Rheumatoid Arthritis. RA is systemic autoimmune disease characterized by chronic inflammation of joints and synovial tissue inflammation, leading to pain, swelling, bone erosion and disability. Biomarker for the confirmation of the disease used is Anti CCP (Anti-cyclic citrullinated peptide).
Swedana in the form of Parisheka is used. Compared with Shobhanajan Twak Qwatha Parisheka and Dhanyamla Parisheka with the duration of 30 minutes of parisheka per day, and course of treatment is 7 days. Before and After result will be compared based on subjective and objective parameters. |