Study the effect of therapeutic purgation followed by herbal formulation in the management of Non Alcoholic Fatty Liver Diseases (NAFLD)
- Conditions
- Other specified inflammatory liverdiseases. Ayurveda Condition: YAKRUDDALYUDARAH,
- Registration Number
- CTRI/2023/06/053635
- Lead Sponsor
- National Institute of Ayurveda
- Brief Summary
Non alcoholic fatty liver disease (NAFLD) is emerging as the most common liver disorder in industrialized countries and in many developing countries. It exists as a histologic spectrum, ranging from simple steatosis or steatosis with only mild inflammation (Type 1 and 2 NAFLD) to more severe steatohepatitis (type 3 and 4 NAFLD) or non-alcoholics steatohepatitis (NASH). Type 1 and 2 NAFLD infrequently progress to cirrhosis but type 3 and 4 NAFLD i.e(NASH) progress to cirrhosis in as many as 15%to 20% of patients. In addition to the usual complication of Cirrhosis and portal hyper tension, hepato cellular carcinoma is now recognized as a late complication of NAFLD. Because of its potential to cause life threatening complication it has been kept top priority in the public health administration.
Non alcoholic fatty liver disease occurs in every age group people, but especially in people in the age group 40s and 50s who are at high risk of heart disease because of such risk factors as obesity and type2 diabetes. This condition is also closely linked to metabolic syndrome which is a cluster of abnormalities including increased abdominal fat poor ability to use the hormone insulin, high blood pressure, and high triglyceride level in the blood.
Here comes the role of *Ayurveda* which describes a wide variety of measures of managing the hepatic disorder including Fatty Liver, under the broad description of *Yakritodara*. It describes mainly hepato-protective and hepato-regenerative herbal agents which are trusted and tested and have simultaneously got the hepato protective effects and therefore thought to be extremely useful in the pathogenic conditions like Fatty liver.
**Prevalence of disease: -**
Over the past couple of decades, it has become clear that nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is the significant cause of liver disease. The prevalence of Fatty liver diseases in India is found to be as high as 24% which is similar to that reported in some of the western countries where it correlates with the prevalence of obesity.
**REASEARCH QUESTION**: -
Whether the *Vi**rechana Karma* followed by *Manadya Gutika* orally is effective in the management of *Yakritodara* with special reference to Non Alcoholic Fatty liver Disease (NAFLD) ?
**HYPOTHESIS:-**
**NULL HYPOTHESIS(H0):-**
There is no effect of *Virechana Karma* followed by *Manadya Gutika* orally in the management of *Yakritodara* with special reference to Non Alcoholic Fatty Liver Disease(NAFLD).
**AIM AND OBJECTIVES: -**
**AIM: -**
To conduct a clinical trial to evaluate the efficacy of *Virechena Karma* followed by *Manadya Gutika* orally in the management of *Yakritodora* with Special reference to Non Alcoholic Fatty Liver Disease (NAFLD).
**OBJECTIVES: -**
To evaluate the efficacy of *Virechana Karma* followed by *Manadya Gutika* orally in the management of *Yakritodora* with special reference to NAFLD.
**MATERIALS AND METHODS: -**
**A.** **SELECTION OF CASES: -**
For the current study, 30 patients of NAFLD will be selected randomly from OPD & IPD of NIA Hospital, Jaipur fulfilling the inclusion criteria of the study on the basis of International NAFLD score along with USG abdomen report, irrespective of religion, occupation and Socio-economic status. Details of consent will be explained, and written consent of each patient will be taken on prescribed Performa.
B. **CLINICAL STUDY**:-
Study Type**:-** Interventional ,Open level study.
Study Site :- OPD/IPD of National Institute of Ayurveda Hospital, Jaipur.
Sample Size :- 30patients.
Masking :- Open
Timing :- Prospective
End point :- Efficacy Study.
**a)** **Inclusion Criteria:**
1) Patient aged between 18 to 60 years of either sex not taking any medicine will be included in the study.
2) Individual suffering from NAFLD will be included.
3) Patient fit for *Virechana Karma.*
4) Patient willing to give informed consent for the study.
**b)** **Exclusion criteria: -**
1) Individual suffering from Chronic hepatitis, malignant Jaundice, acute hepatitis (other than infective).
2) Individual with any psychiatric illness which may impair the ability to provide written ICF.
3) Individual participating in any other clinical trial.
4) Pregnant or lactating females.
5) Alcohol, Smoke and Drug abuser will be excluded from the study.
4
**c)** **Withdrawal criteria: -**
1) If any patient by taking the trail drugs of *Virechana* and *Mandya Gutika*, develops any side effect or any patient cannot follow the instruction.
**D) CRITERIA OF DAIGNOSIS**:
The diagnosis will be made on the basis USG upper abdomen report, NFALD Score and sign and symptoms of the diseases.
**E) CRITERIA FOR ASSESMENT: -.**
Subjective and objective parameters will be made out to assess the clinical response in the total number of patients before treatment and after treatment.
**A) NAFLD Score (Objective Parameter)**
For assessing the NAFLD case the international score is taken as reference.
**NAFLD Score**
**(Reference: -Angulop,Hui JM,Marchesini G etal.**
**Official Journal of the American Association for the study of Liver Disease,2007,45(4))**
Age(years) ---
BMI(kg/m2) ---
IGF/diabetes --
AST --
ALT --
Platelets(X10^6/l)—
Albumin(g/l) ---
(Calculate score)
Formula for Calculation: --1.675+0.037 X Age (years) + 0.094 X BMI(kg/m2)+1.13 X IFG/diabetes (yes=1, no=0)+0.99X AST/ALT ratio-0.013X Platelet(x109/l)-0.66Xalbumin(g/dl)
If the **NAFLD Score > 5** , then the patient will be consider as a **NAFLD case**
**5**
**B) *ARUCHI* (ANOREXIA):**
1—Loss of appetite without alteration in eating habits.
2—Desire for food little late than normal time
3—Desire for food only after long interval
4— No desire at all.
**C) *UDARA SULAH* (ABDOMINAL DISCOMFORT):**
1—No pain and discomfort
2—Mild pain and discomfort
3—Moderate pain diffused over whole abdomen
4—Severe pain over Abdomen
**Laboratory Investigation:**
**i)** **Blood investigation:**
1-FBS
2.LFT
3-Platelate
4-Serum Cholesterol
| | | | | |
| --- | --- | --- | --- | --- |
|Sl.No
Drug name
Botanical Name
Part Used
Quantity
|1
*Vidanga*
*Embelia ribes*
Seed
1 part
|2
*Vara/Triphala*
*Embelica officinalis*
Fruit Pulp
3 parts (1part each)
|*Terminalia chebula*
|*Terminalia belerica*
|3
*Yava suka*
*Horedeum vulgare*
Kshar
1Part
|4
*Kana*
*Piper longum Linn*
Fruit
1part
|5
*Trivrit*
*Operculina turpethum*
Root
3parts
|6
*Honey*
As required
**Method of Preparation: -**
Seeds of *Vidanga,Vara, Yavasuka, and Kana* ,all will be in equal quantity and *Trivrit* half of the total of the above drugs will be taken in powder form and licked with Honey .
**Sl.No**
**Drug Name**
**Botanical Name**
**Part used**
**Quantity**
1
*Mankand*
*Alocacia indica*
Rhizome,Leaf
36gm/3tola
2
*Apamarga*
*Achyranthes aspera*
Seed
36gm/3tola
3
*Guduchi*
*Tinospra cordifollia*
Stem
36gm/3tola
4
*Vasa*
*Adhatoda vasika*
Leaf
36gm/3tola
5
*Sthira /Shalparni*
*Desmodium Gangeticum*
Whole plant
36gm/3tola
6
*Chitraka*
*Plumbago zeylanica*
Root bark
36gm/3tola
7
*Saindhav lavana*
*Rock salt*
36gm/3tola
8
*Sunthi*
*Zingiber Officinale*
Dried Rhizome
36gm/3tola
9
*Tala khanda*
*Borassus flabellifer*
Fruit
36gm/3tola
10
*Go Mutra*
Cow urine
384gm/32 tola
11
*Madhu*
*Honey*
Honey
144gm/12tola
**Method of Preparation**: --
All selected drugs will be taken 36gm (3 *tola*) each and will be made it to powder form then these powder drugs will be boiled in 384gm(32 *tola*) cow urine till it will turn to semisolid and then 144gm(12 *tola)* honey will be added to it .Finally this will be prepared as *Manady Gutika* as trial drug for this study.
| | | | | |
| --- | --- | --- | --- | --- |
|**Sl.No**
**Drug Name**
**Botanical Name**
**Part used**
**Quantity**
|1
*Mankand*
*Alocacia indica*
Rhizome,Leaf
36gm/3tola
|2
*Apamarga*
*Achyranthes aspera*
Seed
36gm/3tola
|3
*Guduchi*
*Tinospra cordifollia*
Stem
36gm/3tola
|4
*Vasa*
*Adhatoda vasika*
Leaf
36gm/3tola
|5
*Sthira /Shalparni*
*Desmodium Gangeticum*
Whole plant
36gm/3tola
|6
*Chitraka*
*Plumbago zeylanica*
Root bark
36gm/3tola
|7
*Saindhav lavana*
*Rock salt*
36gm/3tola
|8
*Sunthi*
*Zingiber Officinale*
Dried Rhizome
36gm/3tola
|9
*Tala khanda*
*Borassus flabellifer*
Fruit
36gm/3tola
|10
*Go Mutra*
Cow urine
384gm/32 tola
|11
*Madhu*
*Honey*
Honey
144gm/12tola
**Method of Preparation**: --
All selected drugs will be taken 36gm (3 *tola*) each and will be made it to powder form then these powder drugs will be boiled in 384gm(32 *tola*) cow urine till it will turn to semisolid and then 144gm(12 *tola)* honey will be added to it .Finally this will be prepared as *Manady Gutika* as trial drug for this study.
Assessment will be done beforetreatment and after treatment based on subjective and objective parameter.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
1-Individual suffering from NAFLD will be included 2-Patient fit for virechana karma 3-patient willing to give informed consent for the study.
- 1- Individual suffering from Chronic hepatitis,Malignant jaundice, acute hepatitis( other than infective) 2- Individual with any psychiatric illness which may impair the ability to provide written ICF.
- 3-Individual participating in any other clinical trial.
- 4- Pregnant or lactating females 5-Alcohol,smoke, and drug abuser will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in NAFLD score. 45 days
- Secondary Outcome Measures
Name Time Method Changes in subjective parameter and Changes in USG upper abdomen 45 days
Trial Locations
- Locations (1)
National Institute Of Ayurveda,Jaipur
🇮🇳Jaipur, RAJASTHAN, India
National Institute Of Ayurveda,Jaipur🇮🇳Jaipur, RAJASTHAN, IndiaDr Gopesh MangalPrincipal investigator8619849011gmangal108@gmail.com