Effectiveness of Vaishwanara Choornam and Drakshadi Kashayam aqueous extract in Non-Alcoholic Fatty Liver Disease
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Reduction in grades of fatty liver as identified by echogenicity of liver through USG abdomen.
Study Overview
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) has a global prevalence of 25% and is a leading cause of cirrhosis and hepatocellular carcinoma. NAFLD encompasses a disease continuum from steatosis with or without mild inflammation (non-alcoholic fatty liver), to non-alcoholic steatohepatitis (NASH), which is characterized by necroinflammation and faster fibrosis progression, NAFLD has a bidirectional association with components of the metabolic syndrome, and type 2 diabetes increases the risk of cirrhosis and related complications
NAFLD may be corelated with Satarpana janya vyadhis due to intake of nidanas there is resultant agnimandyam causing ama formation and vitiation of Kapha and medas leading to accumulation in Yakrith which is Pittasthana as the disease advances it can result in Dhatupaka (necroinflammation) NASH , the final phase of the disease is characterized by increase of Vata Gunas resulting in fibrosis & cirrhosis.Hence the medicines selected should possess the qualities like deepana,pachana, srothosodhana,vatanulomana and yakruthprasadana.
The study drug Vaishwanara choornam,and Drakshadi Kashyam mentioned in Ashtang Hrudya gulma chikitsa and jwara chikitsa respectively ,the formulation will be prepared according to the methods adopted from classical Ayurvedic textbooks for choornam and in dose adjusted Kashaya aqueous extract form with date of administration labelled in it for 60 days. An interventional pre – post study in a single group will be conducted in participants attending OPD of Department of Kayachikitsa at Government Ayurveda College, Thiruvananthapuram. Participants will be advised to take Vaishwanara Choornam in dose of 6g with Drakshadi Kashyam administered as whole Kashaya aqueous extract at a dose of 3gm (1 sachet) with 96 ml lukewarm water twice daily at 6AM,6PM for a period of 60 days. A total of 120 kashaya aqueous extract sachet and 120 packets of vaishwanara choornam, 30 packets of aqueous extract of kashayam and 30 packets of choornam will be given to the participants in each visit at an interval of 15days.After collecting baseline data participant will be evaluated on the 0th and 61st day. USG, Scoring and Blood parameters are done before and after the study. The results obtained will be statistically analyzed and concluded.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and Female participants of age group between 25-65 years of age having Grade 1 and Grade 2 Non-Alcoholic Fatty Liver Disease diagnosed through ultrasonography.
Exclusion Criteria
- •Known history of any serious systemic illnesses.
- •Pregnant and lactating women.
Outcomes
Primary Outcomes
Reduction in grades of fatty liver as identified by echogenicity of liver through USG abdomen.
Time Frame: 60 days
Secondary Outcomes
- Reduction in Elevated Liver Enzymes.(Reduction in NAFLD Fibrosis Score.)
Investigators
Dr Nidhish Nair
Government Ayurveda Medical College and Hospital, Thiruvananthapuram