| CTRI Number |
CTRI/2025/04/085390 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the efficacy of Vyadhi Shardula Guggulu and Simhanada Guggulu along with Rasna Dashamula Kwatha in the management of Amavata (rheumatoid arthritis). |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate the efficacy of Vyadhi Shardula Guggulu and Simhanada Guggulu along with Rasna Dashamula Kwatha 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 |
MANISH PALIWAL |
| Designation |
PG Scholar |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
Department of Kayachikitsa National Institute of Ayurveda Deemed to be University, Near Jorawar Singh Gate, Amer Road, Jaipur
MADHAV VILAS, AMER ROAD, JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8982187592 |
| Fax |
|
| Email |
manishpaliwal02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sahu |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kayachikitsa National Institute of Ayurveda Deemed to be University, Near Jorawar Singh Gate, Amer Road, Jaipur
National Institute of Ayurveda Deemed to be University, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Sahu |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Kayachikitsa National Institute of Ayurveda Deemed to be University, Near Jorawar Singh Gate, Amer Road, Jaipur
Department of Kayachikitsa National Institute of Ayurveda Deemed to be University, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa National Institute of Ayurveda Deemed to be University, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be University Jaipur |
| Address |
Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Near Jorawar Singh Gate Amer Road Jaipur |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MANISH PALIWAL |
Hospital of National Institute of Ayurveda, Deemed to be University, Jaipur |
OPD No. 1, 7, at National Institute of Ayurveda Hospital, Jorawar Singh Gate, Amer Road, and Seth Surajmal Bombay Wala Hospital, Jaipur
Jaipur
RAJASTHAN |
8982187592
manishpaliwal02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda DEEMED TO BE UNIVERSITY JORAWAR SINGH GATE AMER ROAD JAIPUR - 302002 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AMAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhanada Guggulu, Reference: Chakradutta Amavatachikitsaprakran 25/31-36, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Lukewarm Water ), Additional Information: -(2) Medicine Name: Rasna Dashamula kwatha, Reference: Chakradutta Amavatachikitsaprakran 25/5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Eranda taila (5ml)), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyadhi Shardula Guggulu, Reference: Bhaishajya Ratnavali Amavatarogadhikar 29/168-175, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Lukewarm Water ), Additional Information: -(2) Medicine Name: Rasna Dashamula kwatha, Reference: Chakradutta Amavatachikitsaprakran 25/5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: Eranda taila (5ml)), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, aged 25 to 60 years.
Patients exhibiting signs and symptoms of Amavata (Rheumatoid Arthritis).
Patients who fulfill the criteria of ACR/EULAR 2010 criteria (American College of Rheumatology/European League Against Rheumatism).
Patients with a chronicity of less than 5 years. |
|
| ExclusionCriteria |
| Details |
Patients with severe crippling joint deformities.
Patients with associated cardiac disease, uncontrolled diabetes mellitus, malignant hypertension, or any conditions that may interfere with the outcome of interest.
Pregnant women and lactating mothers.
Patients taking disease-modifying anti-rheumatic drugs (DMARDs) for rheumatoid arthritis. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in disease activity as measured by the DAS-28 score. |
Baseline and 8 weeks. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Changes in symptom score.
Changes in the HAQ-DI score.
Changes in functional capacity by assessing walking time, hand & foot grip.
Changes in inflammatory markers: ESR, CRP. |
Baseline, 4 weeks, & 8 weeks |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="28" |
|
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
|
RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VYADHI SHARDULA GUGGULU ANDSIMHANADA GUGGULU ALONG WITH RASNA DASHAMULA KWATHA IN THE MANAGEMENT OF AMAVATA (RHEUMATOID ARTHRITIS)Background: Amavata is a clinical entity vividly described by Madhavakara in 7th Century AD with well-defined aetio-pathogenesis and clinical presentation with specific emphasis Mandagni (reduced digestive fire) and Ama playing the central role and it affects the Rasavaha srotas (channels carrying nutrient fluid). This condition is can be comparable to Rheumatoid Arthritis because of the similar clinical presentation. Amavata is an inflammatory disease involving all the three Doshas embedded with Ama. Amavata develops due to vitiated Vata along with Ama well as Vata dosha. NULL HYPOTHESIS (H0)- There is no difference in the efficacy of Vyadhi Shardula Guggulu and Simhanada Guggulu along with Rasna Dashamula Kwatha in the management of Amavata (Rheumatoid Arthritis). ALTERNATE HYPOTHESIS (H1) There is difference in the efficacy of Vyadhi Shardula Guggulu & Simhanada Guggulu along with Rasna Dashamula Kwatha in the management of Amavata (Rheumatoid Arthritis). AIM: To compare the efficacy of Vyadhi Shardula Guggulu and Simhanada Guggulu along with Rasna Dashamula Kwatha in the management of Amavata (Rheumatoid Arthritis)? OBJECTIVES: Primary objective: To evaluate and compare the efficacy of of Vyadhi Shardul Guggulu and Simhanada Guggulu by Change in disease activity score by DAS-28 score Secondary objective: To evaluate and compare the Changes in Symptom Score To evaluate and compare Changes in The Health Assessment Questionnaire Disability Index (HAQ- DI)13 To evaluate and compare Changes in Inflammatory Markers ESR and CRP. To evaluate and compare Changes in Functional Capacity by Assessing the Walking Time, Hand & Foot Grip. Study Design: Randomized clinical Trial, Comparative study Study type: Interventional, Prospective study Phase of clinical trial: Phase II
No. of Groups: Two 50 participants (25 in each group) Duration of Study : 56 days (8 weeks) Descriptive statistics: Mean, median, Mode, Inter quartile range, Minimum and maximum, percentage, frequency Inferential Statistics: Test of hypothesis testing For intra group assessment of nonparametric data Wilcoxon matched-pairs signed ranks test will be used, while for Parametric Data Paired âtâ Test will be used For intergroup comparisons and nonparametric variables Mann-Whitney Test will be used while for Parametric variables Unpaired âtâ Test will be used
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