Important
Please note that patients who suffer from jaundice and serious liver disorders, should avoid salt and oil, drink more boiled jeeraka water or tender coconut water and should stick to a bland vegetarian diet until their system becomes normal. In normal cases, there is no such above mentioned restrictions.
Synopsis of Clinical Evaluation of KAMILARI:
(Conducted by: Kasturba Medical College, Manipal)
Clinical evaluation of KAMILARI - an Ayurvedic Drug in the Management of Viral Hepatitis and Jaundice.
Annie Shrwaikar, Sreenivasan. K.K, Nagaraj. K
KAMILARI - a popular marketed antihepatotoxic ayurvedic preparation which has been clinically evaluated for its efficicacy in viral hepatitis. The study showed that KAMILARI was useful as an antihepatotoxic agent as it significantly reduced serum bilirubin. ALT and AST values within a week of treatment.
Introduction:
KAMILARI is an ayurvedic preparation recommended as effective in the treatment of jaundice, acute and chronic inflamatory liver disorders, dyspepsia, loss of appetite, alcoholism, etc. This drug has received wide acceptance, as evidenced from local newspaper reports. Animal experiments have shown encouraging results. The present study was aimed at evaluating the safety and the effect of the drug.
Composition:
KAMILARI consists of the following ingredients. Thespesia populnea, Elettari cardamomum, Zingiber officinalis, Glycyrrhiza glabra and honey.
Thespesia populnea, the main component of the formulation has been found to be interestingly endowed with hepatoprotective activity 2.
A survey of literature revealed that Glycyrrhiza glabra 3 and Piper nigrum 4 were useful antihepatotoxics.
Materials and Methods :
Clinical trials were carried out at the KMC Hospital, Manipal. forty patients suffering from confirmed viral hepatitis were chosen for the study. All patients selected were drug free for atleast 2 weeks perior to the study. The study was divided into 2 groups comprising of 20 patients each.
Group A: Patients were administered with KAMILARI, 2 tablespoonful (30), orally, t.i.d. before meals for 2 weeks.
Group B: Patients served as control and confined on conventional treatment
i.e. vitamin B complex and fluids.
All the cases were advised a diet that was fat and spice free through the course of study. Assessment was done once a week for clinical and biochemical parameters.
Clinical : Jaundice, nausea, vomiting, anorexia, diarrhoea, colour of urine, liver enlargement and spleen enlargement.
| Age (Yrs.) |
Group A |
Group B |
| |
Male |
% |
Female |
% |
Total |
Male |
% |
Female |
% |
Total |
| 10 - 20 |
6 |
60 |
2 |
20 |
8 |
4 |
40 |
8 |
80 |
8 |
| 20 - 30 |
4 |
40 |
2 |
20 |
6 |
2 |
20 |
0 |
0 |
5 |
| 30 - 40 |
0 |
0 |
0 |
0 |
0 |
4 |
40 |
0 |
0 |
0 |
| 40 - 50 |
6 |
60 |
0 |
0 |
6 |
2 |
20 |
0 |
0 |
6 |
| Clinical Investigation |
|
Group A |
Group B |
| Clinical Symptoms |
Day 0 |
Day 7 |
Day 14 |
Day 21 |
Day 0 |
Day 7 |
Day 14 |
Day 21 |
| Anorexia |
10 |
- |
- |
- |
20 |
12 |
6 |
2 |
| Abdominal discomfort |
6 |
- |
- |
- |
10 |
4 |
- |
- |
| Lethargy |
20 |
- |
- |
- |
20 |
14 |
8 |
2 |
| Nausea |
20 |
- |
- |
- |
20 |
12 |
4 |
2 |
| Jaundice |
18 |
- |
- |
- |
20 |
16 |
6 |
2 |
| Dark urine |
20 |
8 |
3 |
- |
20 |
14 |
4 |
2 |
| Enlarged Liver |
16 |
2 |
2 |
- |
16 |
12 |
6 |
2 |
|
|
Without trial drug |
With trial drug |
|
|
No. of cases |
Before treatment
7 days |
After treatment
14 days |
No. of cases |
Before treatment
7 days |
After treatment
14 days |
|
Serum
Bilirubin
D+ S.E./t/ |
20 |
1.5 + 0.3
5 |
3.0 + 0.425
7.04 |
20 |
2.84 + 0.364
7.8 |
3.44 + 0.444
7.75 |
|
SGPT
D= S.E./t/ |
20 |
396.5 + 141.5
2.8 |
519.3 + 141.56
3.66 |
20 |
758.3 + 139.08
5.45 |
315.3 + 147.89
5.51 |
|
SGOT
D+S.E./t/ |
20 |
716.3 + 178.67
4.0 |
815.5 + 186.56 |
20 |
417.63 + 56.94
7.33 |
592.25 + 78.63
7.57 |
N.B./t/=D Where D is the arithmatic mean of paired differences (before and after treatment)
Biochemical :
Serum bilirubin AET & AST
Observations :
The age and sex incidence of the cases selected are shown in Table 1 clinical investigations in Table 2 and biochemical investigation in Table 3.
Discussion :
Clinically the patients treated with trial drug exhibited a satisfactory response. From Table 2 it can be observed that the
symptoms anorexia, abdominal discomfort, lethargy, nausea and jaundice disappeared within a week of treatment with KAMILARI. Liver enlargement however persisted in 12% cases. In the untreated group B however nearly 30 % patients still showed clinical symptoms of viral hepatitis after 2 weeks. As recorded in Table 3. the "t" test showed significant reduction in the serum reduction in the serum bilirubin. ALT & AST values within 7 days of treatment itself compared to the untreated group.
Conclusion :
The result in the present study therefore indicate that KAMILARI could be a valuable therapy for patients suffering from viral hepatitis.
References :
- Shirwaikar Annie, Vasanth Kumar A, Krishnanand BR,
Sreenivasan K.K, Indian Drugs, 1991.29.5
- Shirwaikar Annie, Vasanth Kumar A, Krishnanand BR,
Sreenivasan K.K, Int J Pharmacognosy 1996
33.(4)305-310
- Kioso Y, Suzuki Y, Watanabe N.Oshima Y. Hikkino,
11 Planta Med, 1984, 50.238
- Rege. N. Dahanukar.S. Karandikar S.M.
Indian Drugs 1984,21,544-545
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