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To understand the efficacy of Mallotus nudiflorus (L.) (traditionally used substitute of Gambhari) and Gambhari (Gmelina arborea roxb.) in the patients of Sotha( General oedema)

Phase 2/3
Not yet recruiting
Conditions
Generalized edema. Ayurveda Condition: SOTHAH, (2) ICD-10 Condition: R601||Generalized edema. Ayurveda Condition: SVAYATHUH/SOTHAH/SOPAH,
Registration Number
CTRI/2023/08/056897
Lead Sponsor
ITRA Hospital
Brief Summary

This trial is randomized clinical trial to evaluate the efficacy of Mallotus nudiflorus (L.) in comparison to Gambhari (Gmelina arborea Roxb) in the management of Sotha. total 30 patients will be enrolled in the study. Selected patients will be divided into two groups on the basis of computer-generated randomization. in this study group A will be given Kwath of stem bark of Mallotus nudiflorus (50 ml twice a day after food ) for two weeks. and in Group B kwatha of stem bark of Gambhari (Gmelina arborea Roxb) (50 ml twice a day after food ) for two weeks.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

1.Patients presenting with the classical signs and symptoms of Shotha with less than 3 months of chronicity except Paittika Shotha and inflammatory swellings due to Abhighata or other causes 2.Patients of will be selected irrespective of sex,religion etc 3.Patients aged between 25-75 years.

Exclusion Criteria
  • 1.Patients suffering from any systemic uncontrolled disease-like Diabetes(>180mg/dl), Hyper tension (>160/100mm of Hg), Cardiac anomaly, Chronic renal failure, Liver cirrhosis, filariasis etc.
  • 2.Pregnant or lactating mother 3.Patients exhibiting lakshanas of Paittika Shotha and inflammatory swellings due to Abhighata or other causes.
  • 4.Patients suffering from any auto immune diseases.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in condition will be assessed on the basis of changes in scoring patterns and measurements of affected partsChanges in the Signs and Symptoms with measurements of affected parts will be assessed on zero and 14th day.
Secondary Outcome Measures
NameTimeMethod
Change in routine Biochemistry, Blood & Urine investigations on 0th and 14th dayzero & 14th day
changes in routine Biochemistry, Blood & Urine Investigation before & after treatmentzero & 14th day

Trial Locations

Locations (1)

ITRA Hospital

🇮🇳

Jamnagar, GUJARAT, India

ITRA Hospital
🇮🇳Jamnagar, GUJARAT, India
Vijaya Lekshmi R
Principal investigator
9567996480
lekshmivijaya992@gmail.com

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