A Case Study OfA Case Study Of

Chronic Hepatitis B & CChronic Hepatitis B & C

Presented by:Presented by:

Hk.M.Ahmad SaleemiHk.M.Ahmad Saleemi

A Case Study OfA Case Study Of

Chronic Hepatitis B & CChronic Hepatitis B & C

Presented by:Presented by:

Hk.M.Ahmad SaleemiHk.M.Ahmad Saleemi

Hepatitis:

Hepatitis is an inflammation of the liver characterized by the presence of inflammatory cells in the tissue of the organ.

Viral Hepatitis:

Viral hepatitis is liver inflammation due to a viral infection. It may present in acute (recent infection, relatively rapid onset) or chronic forms. The most common causes of viral hepatitis are the five unrelated hepatotropic viruses Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, and Hepatitis E. In addition to the hepatitis viruses, other viruses that can also cause hepatitis include Herpes simplex, Cytomegalovirus, Epstein-Barr virus, or Yellow fever Virus.

Hepatitis-BChronic hepatitis B is a major global healthcare problem. Affecting an estimated 350 to 400 million people worldwide,1,Chronic hepatitis B results in approximately one million deaths each year,2 Making it the world's tenth leading cause of death.In the US,1 to 1.25 million people have chronic hepatitis B,and approximately 4000 to 5000 die each year of its complications.3 The progression of chronic hepatitis B is variable, ranging from mild asymptomatic infection to severe chronic liver disease. In about 15% to 25% of patients, ongoing viral replication leads to serious complications including hepatic decomposition, cirrhosis, and Hepatocellular carcinoma (HCC). - 4-5 Million people in Pakistan.

Hepatitis-C

• - 170 million people are chronic carrier of Hep-C i.e.3 % of world population.

• - 2-4Million Persons in USA may be Chronically affected.

• - 5-10 Million in Europe.• - 12 Million in India • - 4-6 Million in Pakistan• * Source:

http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index4.html

Modes Of Transmission

Difference between Hepatitis Difference between Hepatitis TypesTypes

HAV HBV HCV HDV HEV

Size of Virus 40 nm 42 nm 30 nm 40 nm 30 nm

Type of Nucleus RNA DNA RNA RNA RNA

Vaccine Available Yes Yes No No No

Mean Incubation Time 25 Days 75 Days 50 Days 35 Days Unknown

Chronic Infection No Yes Yes No No

Mode of Transmission Fecal or oral

Sexual Trans

Blood Trans

Blood Trans

Fecal

Signs & Symptoms

• Malaise( َق�راری بے ۔ چینی ( بے• Anorexia (Poor appetite)( کمی کی (بھوک• Nausea( ابکائیاں ( متلی۔• Abdominal pain( درد شکم )• Tenderness(نرمی)• Muscle & Joint Pain( درد پٹھاوجوڑ )

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Diagnostic Tests A. Biochemical Indicators

B. ELISA (Enzyme Linked Immune Sorbent assay)

C. RIBA (Recombinant Imunoblot assay)

D. PCR (Detects RNA of the actual HCV) Qualitative PCR Quantitative PCR

E. Liver Biopsy. F. Other Biochemical Tests.

Hb TLC Alkaline Phosphatase Bilirubin ESR etc.

ALT0 – 20 times.

AST

TREATMENT A. Mono therapy with alpha interferon.

Work in 10 – 20 person out of 100.• Side effect profile is high

Dosage reduced in 40 out of 100.Treatment withdrawn in 15.

• Pregnant can not use.B. Combination therapy Interferon + Ribavirin

Works in 30 – 40 out of 100Ribavirin alone does not work.Serious side effects like severe anemia myocardial infarction

The challenge of science

• Paracelsus, the Father of Pharmacology said..“All that mankind needs for good health andhealing is provided in nature..the challenge of science is to find it!”

Herbal Treatment

Main Ingredients

1. Glycyrrhiza (Mulathi) 2. Silybum marianum(Oont Catara)

3. Withania coagulans (Paneer Doodi) 4. Solanum nigrum Linn (Mako) 5. Piprum nigrum(Mirch sia)

66. Artemisia absinthium(afsanteen)7.Chichorium intybus(kasni)

8.Aloe Vera (Kanwar Gundal)

Silibum marianum(Oont Catara)

- Milk thistle has been used for liver problems for over 2000 years

- It offers Hepato-protective action through a number of mechanisms

- Anti-oxidant activity - Toxin blockade at the membrane level- Enhances protein synthesis- Anti fibroitic activity- Anti-inflammatory and - Immune-modulating effects.

Silybum marianum has been shown to have clinical applications in the treatment of toxic hepatitis, fatty liver, cirrhosis, ischemic injury, radiation toxicity and viral hepatitis.

- Significantly reduces insulin requirements

It also significantly reduces insulin requirement in cirrhosis related diabetes mellitus patients.

Silybum marianum (Oont Catara)

OUTSTANDING EFFICACY IN LIVER DISORDERS

• Glycyrrhiza Glabra offers out standing surveillance rate in liver patients.•Reduces The Risk Of Liver Carcinoma •Glycyrrhiza Glabra has reduced half the rate of hepatocellular carcinoma as compared to other supportive therapy.•Restores Liver Functions •Hepatitis treatment with Glycyrrhiza Glabra restores AST & ALT plasma concentrations.

Glycyrrhiza glabra (Mulathi)

IMPROVES LIVER FUNCTIONS• Increases thyroxine (T4), hepatic glucose and decreases liver lipid peroxidation. •Anti Inflammatory Action•Anti-inflammatory action is comparable to hydrocortisone. • Reduces Hepatotoxicity• Hepatotoxicity is reduced by withania comparable to hydrocortisone.

Withania coagulans (Paneer Doda)

Black pepper has stimulant, expectorant, carminative, antipyretic, anthelmintic, antiperiodic action when used internally and externally it acts as rubefacient, stimulant, resolvent. Pepper has long been known for stimulating the appetite and relieving nausea. In India it had been used as a medicine for variety of ailments from paralysis to toothache. According to Ayurveda it is useful in treatment of asthma, chronic indigestion, colon toxins, obesity, sinus congestion, fever, intermittent fever, cold extremities, colic pain, cholera, gastric ailments, diarrhea, piles, worms and sore throat. Externally it can be applied to boils and other skin diseases in form of paste.

DETOXIFYING AGENT- Hepatotoxicity is decreased reducing lipid peroxidation, enzymatic leakage of

GPT, AP and preventing depletion of GSH.

Piper nigrum(Kali mirch or Black pepper )

Chicory (especially the flower) was used as a treatment in Germany, and is recorded in many books as an ancient German treatment for everyday ailments. It is variously used as a tonic and as a treatment for gallstones, gastro-enteritis, sinus problems and cuts and bruises. (Howard M. 1987). Inulin, the dietary fiber found in Chicory finds application in diabetes and constipation.Chicory has demonstrated antihepatotoxic potential in animal studies.,[

Chichorium intybus(Chicory) (Kasni)

Artemisia absinthium(Afsanteen)

• Its active substances include silica, two bitter substances (absinthin and anabsinthine), thujone, tannic and resinous substances, malic acid, and succinic acid. It is used medicinally as a tonic, stomachic, antiseptic, antispasmodic, carminative, cholagogue, febrifuge and anthelmintic. It has also

been used to remedy indigestion.

Compound medicine• Majoon Dabeed ul ward• Jawarish Amla• Dawa ul Qurkum kabir• Dawa ul Misk • Sharbat Deenar• Sharbat Kasni• Sharbat Bazoori• Hepta Care• Akseer e Jiger Syrup & Tab• Aloe Care Cap & Syrup• Jigreen • Actirn Tab• Berisal Syrupetc

Condition Chronic Hepatitis B & C

Investigational drugs.A combination of herbal ingredients mainly Glycrrhiza, Silybum marianum.

Investigational Tests & frequency.

Data collection procedureOn a specific designed format through patient interview & lab reports.

Location of trialPrivate clinicR&D Qarshi IndustriesQarshi Health Shop

One year.One year.Time frameTime frame

Tests Frequency

Hb 3 Week Interval

ALT ““

AST ““

Platelets ““

ESR At start and end of therapy

Urea ““

Biliribin ““

Anti HCV. ““

PCR Quantitative ““

Clinical Trials of Clinical Trials of

Herbal medicine on Hepatitis C PatientsHerbal medicine on Hepatitis C Patients

Hepatitis C Study Hepatitis C Study

PATIENTS & METHODS

All patients who were Hepatitis B surface antigen negative, and had impaired liver functions were tested for Hepatitis C virus antibodies. PCR was done in those who tested positive for HCV antibodies. Patients who had detected virus on PCR and abdominal ultra sound showed no stigmata of portal hypertension were included in the study.

Hemoglobin SGPT (ALT), AST, White cell count. Platelets were done at the interval of every three weeks. Liver function test, Renal function test, PCR was done Pre and Post treatment.

The study comprised of 18 patients (12 males, 6 females)

The mean age was (40 15)

Mean AST 105 30 (N < 40 L/ml)

Mean ALT 115 42 (N < 41 L/ml)

These patients were treated with a combination of herbal ingredients mainly glycyrrhizinate, silybum marianum, zinc compound, withinia coagulant, ginseng, Rheum emodi given in divided doses daily for one year. With serial monitoring of AST, ALT, hemoglobin and platelets.

Of initial 18 patients 5 patients lost follow up. Of the 13 patients who completed this study for 6 months, a subjective improvement was seen in 12 patients (93 %).

Out of 13 only 8 patients completed the study for 11 months ( Recommended duration of treatment is one year).

The response to therapy with Herbal medicine depending on biochemical and molecular biological test (PCR) were as follows.

Improvement in ALT & AST levels 12 (93%)

Results PCR – Non Detected 5 out of 8 (62.5 %)

(in patients taken the medicine for recommended duration i.e. 11 months)

The Mean level of ALT, for the 13 patients who completed the study successfully, fell from (115 42) to 40 24 UL/ml and that of AST fell from (105 30) to 43 21 UL/ml.

There was no major side effect. Two patients complaint of colic pain in abdomen.

Hepatitis C Study

Before After Before After Kits Months

1 Mrs. Bashir 46 182 94 225 106 Negative 13 11

2 Mr. Pervaiz 20 36 43 21 Negative 12 10

3 Mr. Niamat 50 86 24 75 32 Negative 13 11

4 Fehmeeda 55 17 20 48 23 Negative 13 11

5 Ali Amir 30 36 23 41 15 Negative 13 11

6 Mrs. Akram 41 44 72 41 58 Positive 13 11

7 Nasim Akhtar 37 42 28 53 37 Positive 13 11

8 Mr. Nadeem* 21 29 38 22 22 not done 12 10

9 Shah Mohammad** 45 139 78 92 82 Positive 8 7

10 Mehar Sajid** 52 51 68 56 60 Positive 8 7

11 Abdul Hameed** 40 72 58 57 42 Positive 7 6

12 Mr. Jamil** 25 131 84 130 67 Positive 7 6

13 Mr. Abid** 30 130 34 91 28 Positive 6 6

PCRDurationAST ALT

Sr. # NameAge

(Years) Clinical Trials of Clinical Trials of

Herbal medicine on Hepatitis B Patients Herbal medicine on Hepatitis B Patients

Hepatitis B Study

All patients were confirmed Hepatitis ‘B’ surface antigen positive, and had increased SGPT & SGOT levels.

PCR was done and willing patients (child bearing female exempted) were included in the study. Pregnant ladies and patients with diabetes and leumpensated cirrhosis were included.

Hemoglobin, SGPT (ALT), AST, Blood chemistry were done at the interval of every three weeks , pcr was done pre & post treatment.

The study comprised of 10 patients (6 male, 4 female)

 The Mean age was 40

MEAN AST 1300 (N < 40µl/ml)

MEAN ALT 1950 (N < 42 µl/ml)

These patients were treated with a combination of herbal ingredients mainly glycyrrhizinate, silybum marianum, zinc compound, withinia coagulant, ginseng, Rheum emodi given in divided doses daily maximum 180 days with periodic monitoring of AST, ALT & CBC. At the initial stage 10 patients completed the study and showed 100% results within 180 days response was as follows.

Improvement in ALT & AST 10 (100%)

PCR Non Detected 10 (100%)

(Mean period in which PCR became –ve in 155 days)

Mean improvement in ALT & AST

Before 1950 1300

After 22 20

(Mean period 60 days)

No major side effect was reported.

Herbal Treatment Feedback of Hepatitis B Patients

No. of patients registered for Treatment:

- 100 patients

Regular Patients:

- 92 patients

Defaulters:

- 8 patients

PCR Test Reports From Aga Khan University Hospital Karachi

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test Result

Hep-B virus DNA detected / not detected

1 Abdul Hafeez Ali Nawaz 27 DK # 16719 Not detected

2 Ali Asghar Muhammad Usman 47 DK # 16720 Detected

3 Fahmida Ghulam Yaseen 25 DK # 16721 Detected

4 Ghulam Mustafa Muhammad Ismail 35 DK # 16722 Not detected

5 Ghulam Hyder Ali Nawaz 21 DK # 16723 Not detected

6 Khadim Hussain Ahmed Bux 29 DK # 16724 Detected

7 Noor Ahmed Ahmed Bux 30 DK # 16725 Not detected

8 Rafiqe Ahmed Abdul Karim 17 DK # 16726 Not detected

9 Shafiqe Ahmed Abdul Karim 14 DK # 16727 Not detected

10 Sajid Hussain Noor Hassan 18 DK # 16728 Not detected

PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test Result

Hep-B virus DNA detected / not detected

11 Muhammad Islam Ellahi Bux 26 DK # 16755 Not detected

12 Allah Yar Dhani Bux 30 DK # 16756 Not detected

13 Abdul Wahab Yaar Muhammad 22 DK # 16757 Not detected

14 Muhammad Ishaqe Abdul Rahim 20 DK # 16758 Not detected

15 Nisar Ahmed Haji Ghulam Yaseen 22 DK # 16759 Detected

16 Zubair Ahmed Shehzado 10 DK # 16760 Not detected

17 Mai Zohra Shaukat Ali 25 DK # 16761 Detected

18 Shahzad Ali Khuda Bux 20 DK # 16762 Not detected

19 Ali Gohar Abdul Rasheed 18 DK # 16763 Not detected

20 Muhammad Hanif Abdul Wahid 10 DK # 16764 Not detected

PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test Result

Hep-B virus DNA detected / not detected

21 Ali Raza Muhammad Sadiq 16 DK # 16781 Detected

22 Wajid Ali Maula Bux 17 DK # 16782 Detected

23 Sajid Hussain karim Bux 12 DK # 16783 Detected

24 Mai Rukhsana Qurban Ali 22 DK # 16784 Not detected

25 Muhammad Zeesahn Ghulam Akbar 22 DK # 16785 Not detected

26 Amjad Ali Muhammad Aslam 31 DK # 16786 Not detected

27 Muhammad Ameen Rehmat Ali 42 DK # 16787 Not detected

28 Abdul Latif Sher Muhammad 20 DK # 16788 Not detected

29 Daulat Ali Dahar Ali 23 DK # 16789 Not detected

30 Asad Ali Anwar Ali 10 DK # 16790 Not detected

PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test Result

Hep-B virus DNA detected / not detected

31 Abdul Hameed Muhmmad Younis 38 DK # 16831 Not detected

32 Akhtiar Ahmed Bilal Shar 22 DK # 16832 Not detected

33 Atta Ellahi Ameer Bux 15 DK # 16833 Not detected

34 Kalsoom Muhammad Yaqoob 30 DK # 16834 Detected

35 Meer Hassan Abdul Wahid 17 DK # 16835 Not detected

36 Rizawan Sher Muhammad 18 DK # 16836 Not detected

37 Saeed Ahmed Muhammad Yaqoob 30 DK # 16837 Detected

38 Zahid Ali Luqman 20 DK # 16838 Not detected

39 Bashir Ahmed Jamal Din 18 DK # 16839 Not detected

40 Shehzado Muhammad Usman 20 DK # 16840 Not detected

PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test Result

Hep-B virus DNA detected / not detected

41 Jahanzaib Shehbaz Ali 14 DK # 16873 Detected

42 Mai Meerul Shehbaz Ali 30 DK # 16874 Detected

43 Sadia Shehbaz Ali 10 DK # 16875 Not detected

44 Aneeta Shehbaz Ali 12 DK # 16876 Not detected

45 Moomal Sain Dad 30 DK # 16877 Not detected

46 Sanawli Momin Ali 16 DK # 16878 Not detected

47 Gul Hassan Soomer Khan 25 DK # 16879 Not detected

48 Hussana Soomer Khan 20 DK # 16880 Not detected

49 Lal Bux Gul Muhammad 25 DK # 16881 Not detected

50 Noor Muhammad Gul Muhammad 23 DK # 16882 Not detected

PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test Result

Hep-B virus DNA detected / not detected

51 Amjad Ali Muhmmad Yaqoob 28 DK # 16910 Not detected

52 Amina Muhammad Abbass 40 DK # 16911 Not detected

53 Bilal Asghar Abdul Wahab 27 DK # 16912 Detected

54 Khalid Mehmood Mehmood 17 DK # 16913 Detected

55 Ishfaqe Ahmed Abdul Shakoor 15 DK # 16914 Detected

56 Zaheer Ahmed Jailkum Khan 27 DK # 16915 Detected

57 Abdul Razaque Haji Dhollan 32 DK # 16916 Detected

58 Ghulam Mustafa Jeewan Khan 32 DK # 16917 Detected

59 Asad Ali Muhmmad Hussain 12 DK # 16918 Detected

60 Naeem Ahmed Sultan Ahmed 16 DK # 16919 Not detected

PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test ResultHep-B virus DNA

detected / not detected

61 Qaim Din Allah Wadhayo 43 DK # 16941 Not detected

62 Shafiqe Ahmed Anwar Din 10 DK # 16942 Detected

63 Khalil Ahmed Luqman 19 DK # 16943 Not detected

64 Arshad Ali Sabzal 20 DK # 16944 Not detected

65 Khalid Hussain Mitho Khan 20 DK # 16945 Detected

66 Mai Willaitan Mohib Khan 15 DK # 16946 Not detected

67 Allah Wasai Qamar Din 15 DK # 16947 Not detected

68 Farman Ali Jeeand Khan 20 DK # 16948 Detected

69 Insaf Ali Jeeand Khan 10 DK # 16949 Detected

70 Bilal Ahmed Abdul Malik 10 DK # 16950 Detected

PCR Test Reports From Aga Khan University Hospital Karachi Through Collection Unit Dhairki

Sr. No. Patient's Name F/H Name Age AKU Lab. Code PCR Test Result

Hep-B virus DNA detected / not detected

81 Shahida Muhammad Bachal 16 DK # 16980 Not detected

82 Abdul Jabbar Muhammad Chhuttal 22 DK # 16981 Not detected

83 Faiz Muhammad Allah Bux 20 DK # 16982 Not detected

84 Aqib Ali Manzoor Ahmed 12 DK # 16983 Not detected

85 Muhammad Irfan Muhammad Ramzan 12 DK # 16984 Not detected

86 Imam Khatoon Abdul Ghafoor 50 DK # 16985 Not detected

87 Mai Hanifan Mir Muhammad 22 DK # 16986 Detected

88 Niaz Ali Gul Hassan 35 DK # 16987 Detected

89 Mai Sharifan Ghulam Mustafa 35 DK # 16988 Detected

90 Akshay Kumar Roshan Lal 12 DK # 16989 Detected

Herbal Treatment Feedback of Hepatitis B Patients

Observations:

Medication

1. 8 patients out of 100 didn't complete the course of medicine (7 patients left the course and 1 was Cirrhotic patient).

2. 82 patients out of 92 were healthy and feeling better than before taking the medicine.

3. 10 patients out of 92 patients had one of these problems like constipation, flatulence, weakness & insomnia.

Herbal Treatment Feedback of Hepatitis B Patients

Observations:

PCR Test Results:

1. PCR test of 90 patients was conducted to find out the Hepatitis - B virus in patients after treatment.

2. As per PCR Tests Report from Aga Khan University Hospital Karachi, in 66% patients (59 patients) Hepatitis – B virus was not detected.

3. Whereas in 34% patients (31 patients), Hepatitis B + virus was detected.

Herbal Treatment Feedback of Hepatitis C Patients

No. of Patients Registered for Treatment:

- 40 patients

Results:

- Treatment of Hepatitis C Patients under process

- Treatment process will be completed till April 2011

Thanks