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Clinical Trials/CTRI/2025/03/082679
CTRI/2025/03/082679Not yet recruitingPhase 2/3

A randomized comparative clinical trial study to evaluate the efficacy of ruksha purva and sneha purva siravedhana and nityavirechana in yakrutodara with special reference to non-alcoholic fatty liver disease.

Parul Ayurved Hospital1 site in 1 country30 target enrollmentStarted: April 1, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
To reduce fatty liver Index score by performing Panchakarma procedures like Udvartana, Siravedhana and Nitya virechana in NAFLD.

Study Overview

Brief Summary

INTRODUCTION:- Non-Alcoholic Fatty Liver Disease (NAFLD) is the accumulation of fat in liver cells, progressing from simple steatosis to severe conditions like cirrhosis. In Ayurveda, it correlates with Yakritodara, involving tridosha imbalance, mandagni, and medodhatu vikriti. Raktamokshana is effective for pittaja and raktaja vikaras, while Udvartana aids fat metabolism. Nitya Virechana helps eliminate Pitta and Ama, improving liver function.

NEED FOR STUDY:- NAFLD is a growing health concern, especially in low socio-economic populations, as it can progress to severe liver diseases like NASH and cirrhosis if untreated. Modern treatments focus on managing symptoms but have limitations, including side effects and high costs. This study aims to explore the combined effects of Ruksha Purva (Udvartana) and Sneha Purva (Snehapana) Siravedhana in Yakrutodara, addressing a research gap in holistic liver disease management.

Aim**:-**  the efficacy of Ruksha purva and Sneha purva Siravedhana andNitya Virechanain the management of Yakrutodara w.s.r. to NAFLD.

Objectives:-To evaluate the efficacy of Ruksha purva Siravedhana with Nitya Virechana in the management of Yakrutodara.

*-*To evaluate the efficacy of Sneha poorva Siravedhana with Nitya Virechana in the management of Yakrutodara.

-To compare the efficacy of Ruksha purva Siravedhana and Sneha purva Siravyadhana with Nitya Virechana in the management of Yakrutodara w.s.r. to NAFLD.

n  NULL HYPOTHESIS [H0] :-There is no significant difference in the effectiveness of the Ruksha purva and Sneha purva Siravedhana andNitya Virechana in the management of Yakrutodara w.s.r. to NAFLD.

ALTERNATIVE HYPOTHESIS :-(H1) – Ruksha purva Siravedhana andNitya Virechana is more effective in the management of Yakrutodar as compare to Sneha purva Siravedhana w.s.r. to NAFLD*.*

(H2) – Sneha purva Siravedhana andNitya Virechana is more effective in the management of Yakrutodar as compare to Ruksha purva Siravedhana w.s.r. to NAFLD*.*

Ø                                 (H3) – Both Sneha Purva and Ruksha Purva Siravedhana, along with Nitya Virechana, have an equal effect in the management of Yakrutodara w.s.r. to NAFLD*.*

INTERVENTIONS:- [ Duration- 13 days (followup on 20th day)

Group A:- (Sample – 15)

Udvartana with Yava churna + triphala churna – 5 days in the morning for 30 min

Siravedhana*–* on 7th & 12th  day

Nitya virechana with Patola katu Rohinyadi kashaya – 7 days 20 ml BD mixed with equal quantity of water

Group B :- (Sample – 15)

Nitya virechanawith Patola katu Rohinyadi kashaya- 7 days 20 ml BD mixed with equal quantity of water

Udvartanawith Yava  churna +triphala churna– 5 days in the morning for 30 min

*Sneha pana –*2 days prior to Siravedhana

*Siravedhana –*on 7th & 12th day

Diagnostic Criteria

Ajirna

Atilalasrava

Chardi

Aruchi

Adhmana

Vibandha

USG : Whole Abdomen (SOS), BT, CT CBC HIV HBsAG HCV

Objective Criteria:-

-                    SGPT, SGOT

-                    Fatty Liver Index

INCLUSION CRITERIA:-

-            Patients of either gender between the age group of 18 to 60

-          Patients of grade I, II, and III Non- Alcoholic fatty liver disease.

-          Both Diagnosed and Newly diagnosed patients

EXCLUSION CRITERIA:-

-          Patient having history of Ascites, Liver Carcinoma, Liver Cirrhosis, HIV, Anemia.

-          Patients having history of major Systemic Diseases like IHD, Malignancies.

-          Pregnant and lactating women.

  

             -

 I

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients of either gender between the age group of 18 to
  • Patients of grade I, II, and III Non- Alcoholic fatty liver disease.
  • Both Diagnosed and Newly diagnosed patients.

Exclusion Criteria

  • Patient having history of Ascites, Liver Carcinoma, Liver Cirrhosis, HIV, Anemia.
  • Patients having history of major Systemic Diseases like IHD, Malignancies.
  • Pregnant and lactating women.

Outcomes

Primary Outcomes

To reduce fatty liver Index score by performing Panchakarma procedures like Udvartana, Siravedhana and Nitya virechana in NAFLD.

Time Frame: 13 days and follow up on 20th day

Secondary Outcomes

  • To reduce symptoms like Ajirna, Atilalastrava, Aruchi, Chardi, Adhmana, Vibandha(On 13th day)

Investigators

Sponsor
Parul Ayurved Hospital
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Riva Ajaybhai Joshi

Parul Institute of Ayurved

Study Sites (1)

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