Clinical Trial of Liv.52 Drops in Infective Hepatitis – A comparative study with broad spectrum antibiotics and corticosteroids

Agarawal, V.K., M.B.,B.S., M.D., M.R.C.P., D.C.H., F.R.C.P., Professor and Head of the Department of Paediatrics and Meena Sareen, M.B.,B.S., M.D. (Paed.) Research Scholar, M.L.N. Medical College, Allahabad, India.

Hepatic disorders in infancy and childhood continue to pose problems in their management. Viral hepatitis in our country is frequently of prolonged duration with a predisposition to complications like post-hepatitis cirrhosis, chronic cholestasis, subacute necrosis and hepatic failure. Sometimes, though rarely, the disease is fulminant and death ensues in the acute phase. Such cases are commonly those in whom a superimposed nutritional factor increases the susceptibility of the liver cells to necrosis.

The therapy of viral hepatitis assumes immense importance as death from this disease is much more common in India due to the poor standard of nutrition though natural clinical cure occurs with or without residual liver cell damage. There have been no revolutionary advances in the therapy of viral hepatitis and pre-coma and coma, and the various modes of treatments have little effect in altering the course. The only aim of therapy is to support the failing hepatic parenchyma and help regeneration of liver cells, thus restoring liver function. A large number of workers have reported on the effect of Liv.52 (The Himalaya Drug Co.), an indigenous compound on the regeneration of liver cells and its effectiveness in acute infective hepatitis. Jaffari (1969) reports that Liv.52 clears jaundice, improves appetite and brings a sense of well-being. He postulates that it has an anti-inflammatory action and advises its use freely since Liv.52 is free from untoward side effects.

Mukherjee (1971) recommended its use in order to prevent a prolonged course of illness and residual cell damage. Dayal (1970) reported that jaundice regressed and liver function tests showed improvement. A large number of workers have reported on the effects of Liv.52, an indigenous compound, on the regeneration of liver cells and its effectiveness in acute infectious hepatitis. Each ml of Liv.52 drops contains:

Exts. Capparis spinosa 65 mg Cichorium intybus 65 mg Solanum nigrum 32 mg Cassia occidentalis 16 mg Terminalia arjuna 32 mg Achillea millefolium 16 mg Tamarix gallica 16 mg Mandur bhasma 33 mg (Prepared in the juices and decoctions of various hepatic stimulants).

Each tablet of Liv.52 contains: Exts. Capparis spinosa 65 mg Cichorium intybus 65 mg Solanum nigrum 32 mg Cassia occidentalis 16 mg Terminalia arjuna 32 mg Achillea millefolium 16 mg Tamarix gallica 16 mg Mandur bhasma 33 mg (Prepared in the juices and decoctions of various hepatic stimulants).

OBSERVATIONS

The one hundred and twenty five cases ranged in age from 6 months to 12 years. There were 77 males and 48 females.

Table I: Showing the age and sex distribution in 125 cases
Age	6 mths - 3 yrs.	3-6 yrs.	6-9 yrs.	9-12 yrs.
No. of cases	28	30	35	32
Male	20	18	17	22
Female	8	12	18	10

Socio-Economic Status: It was divided into four broad groups according to the classification given by the Government of India 1962 (Bank et al. 1967). Seventy per cent of the patients belonged to class IV, 20% to class III and 10% to class II strata of society. Thus it was observed that the maximum number of cases belonged to class IV stratum of society.

The nutritional status was assessed according to Gomez’ classification (1955) and grade two type of malnutrition was common.

PRESENTING FEATURES

The commonest symptoms were jaundice, anorexia, dark urine, fever, nausea/vomiting. The complaints of abdominal pain and clay coloured stools were next in order of frequency. Oedema of feet was present in 25 cases and generalised oedema was observed in 10 cases. Fifteen cases were having marked drowsiness as well. Liver was palpable in all the cases and was tender in 70%. In 10% cases the liver was firm, splenic enlargement was present in 20 cases.

Enlarged liver

Upto 3 cm	3–6 cm	Beyond 6 cm
75	30	20

LABORATORY FINDINGS

In the study group A, 55 cases had serum bilirubin in the range of 1–5 mg% and 45 cases had above 6 mg% as observed from table III. Ninety five per cent had serum bilirubin below 1 mg% in the third week and 5% had the bilirubin in the range of 1-5 mg%.

Table II: Symptoms observed in 125 cases
Symptoms		No. of cases
1.	Jaundice	125
2.	Anorexia	88
3.	Dark coloured urine	76
4.	Fever	90
5.	Nausea/vomiting	85
6.	Abdominal pain	46
7.	Stools: clay coloured	15
8.	Oedema	25
9.	Pruritis	15
10.	Constipation	10
11.	Diarrhoea	25
12.	Drowsiness	15

Table III: Liver function tests before and after treatment: Showing the values of serum bilirubin initially and at the end of 3 weeks in cases of infective hepatitis cases
Serum bilirubin				Liv.52								Control
Before			1st wk		3rd wk		%		Before		1st wk		3rd wk		%
1.	Less than 1 mg%			–		40		95		95%		–		3		20	80%
2.	1–5 mg%			55		45		5		5%		5		17		5	20%
3.	6–10 mg%			20		10		–				10		5		–
4.	11 and above			25		5		–				10		–		–

In the control group 5 cases had serum bilirubin in the range of 1–5 mg% and 20 cases above 6 mg%. When serum bilirubin was repeated in the third week 80% had serum bilirubin below 1 mg% and 20% had bilirubin in the range of 1–5 mg%.

Improvement in the total serum protein was observed in the third week in all patients in both the groups as observed from table IV.

Table IV: Showing serum protein values initially and in the 3rd week in cases of infective hepatitis
Serum protein in gm%			Liv.52		Control group
Initially			3rd week	Initially	3rd week
1.	3–4 gm%		14	–	2	–
2.	4.1–5 gm%		34	4	12	5
3.	5.1–6 gm%		40	70	6	11
4.	Above 6 gm%		12	26	5	9

Refference: http://www.himalayahealthcare.com/pdf_files/liv231.pdf