To assess the efficacy of Vyadhi Shardula Guggulu and Simhanada Guggulu along with Rasna Dashamula Kwatha in the management of Amavata (rheumatoid arthritis).

Phase 3

Not yet recruiting

• Conditions: Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AMAVATAH,

• Registration Number: CTRI/2025/04/085390
• Lead Sponsor: National Institute of Ayurveda Deemed to be University Jaipur

Brief Summary

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)

**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 ‘t’ Test will be used

For intergroup comparisons and nonparametric variables Mann-Whitney Test will be used while for Parametric variables Unpaired ‘t’ Test will be used

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-07
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in disease activity as measured by the DAS-28 score.	Baseline and 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Changes in symptom score.	Changes in the HAQ-DI score.

Trial Locations

Locations (1)

Hospital of National Institute of Ayurveda, Deemed to be University, Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Hospital of National Institute of Ayurveda, Deemed to be University, Jaipur

🇮🇳Jaipur, RAJASTHAN, India

MANISH PALIWAL

Principal investigator

8982187592

manishpaliwal02@gmail.com