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.
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
Dr Riva Ajaybhai Joshi
Parul Institute of Ayurved
