CLINICAL STUDY on LIV. 52 HB
Summary: In this case a 25 year female who was infertile presented for infertility having married for 9 years. In course of 5 months of treatment which includes 4 months on Liv. 52 HB as in the study the patient turned negative on status of Hepatitis B antigen. The AST and ALT values were reduced to normal values within 2 months of initiation of the treatment. The patient is 5 months through her pregnancy and has tolerated the drug well with no missed abortion or any associated signs of discomfort.
THE CASE STUDY-
The drug Liv. 52 HB has been successfully evaluated in a study which began under the guidance of Dr. P. Patki (Head - Medical Services & Clinical Trials - R&D, The Himalaya Drug Company). The following will detail the study as it has progressed to reach its objectives.
The patient (******* Shah) a 25 year old Hindu female reported along with her husband (******* Shah), a resident of village *********District Singrauli, Madhya Pradesh for infertility. The history of the presenting comlaint was as old as 9 years.
The initial treatment included a mixed approach and used both modern and ayurvedic medicines for treatment. The initial prescription with the treatment starting 12th of February, 2011 and the first follow up on 24th, February, 201 was as follows –
Rx
Tab Liv. 52 - DS
2 TID x 15 days
Tab PANCH NIMBADI BATI
2 TID x 15 days
Syp. DASHMOOLARISHTHA
15 ML BID WITH 15ML FRESH WATER x 15 days
Cap OXYTARD
1 BID x 15 days
Syp. DASHMOOLARISHTHA
10 ML BID WITH 15ML FRESH WATER x 15 days
PROTEIN POWDER
2 TSP. WITH MILK TWICE DAILY
FOLLOW UP 1 - (24/02/2011)
Rx
Tab Liv. 52 - DS
2 QID x 50 days
Syp. PUNARNAVARISHTHA
15 ML BID WITH 15ML FRESH WATER x 50 days
Cap OXYTARD
1 BID x 50 days
Cap MAP-DSR
1 OD x 50 days
Tab. LAMIVIR - HBV
1 OD x 50 days
Tab. BALOX
1 BID X 10 days
Fowllowing this period from 18th of March the treatment was further revised as follows limiting the medications only to Ayurveda –
FOLLOW UP 2 - (18/03/2011)
Rx
Cap. LIV. 52 HB
2 BID x 30 days
Syp. TRIGUNASAVA
10 ML BID WITH 10ML FRESH WATER x 30 days
Cap OXYTARD
1 BID x 30 days
FOLLOW UP 3 - (20/04/2011)
Rx
Cap. LIV. 52 HB
2 BID x 60 days
Syp. TRIGUNASAVA
10 ML BID WITH 10ML FRESH WATER x 60 days
Cap OXYTARD
1 BID x 60 days
FOLLOW UP 4 - (25/05/2011)
The treatment was continuing. This included evaluation of confirmation of pregnancy status and AST, ALT, HbsAG and HCV status.
FOLLOW UP 5 - (19/06/2011)
Rx
Cap. LIV. 52 HB
2 BID x 60 days
Syp. TRIGUNASAVA
10 ML BID WITH 10ML FRESH WATER x 60 days
Cap OXYTARD
1 BID x 60 days
FOLLOW UP 6 - (27/07/2011)
The treatment was continuing. This included evaluation of confirmation of pregnancy status and AST, ALT, HbsAG and HCV status.
At this point after having attained the positive turn in AST and ALT values as early as in May following 2 months of use in July a Negative status has also been attained for Hepatitis B.
Future course as adopted - The patient remains under observation and the new born shall be evaluated at birth for HBsAg Status to confirm safety during pregnancy and also evaluate the prevention of placental transmission of Hepatitis Antigen across to the developing foetus.
Objectives achieved thus far –
1.) In 4 months of time frame Hepatitis stus has been achieved as Negative.
2.) AST and ALT values returned to normal in 2 months of time.
3.) Dependence on a coalesce use of an antiviral drug as lamivudine is not required since the status has been achieved independent of lamivudine once Liv. 52 HB was initiated.
4.) Safe to use during pregnancy by initial observations as no adverse events were reported except for occassional bloating sensations of the stomach.
Further continuing evaluations –
1.) The status of the baby at birth with respect to HbsAg.
2.) Since AST and ALT values have been attained at a normal value and are sustained; a long term use may have a potential impact on HCV status as well.
3.) The patient shall remain under observation for 2 years with observations made 6 monthly since studies show reversal of Hepatitis B status as positive.
4.) Since patients with a dual status of Hepatits B and Hepatitis C positive are at a long term risk of developing Liver Cancer, the extended evaluations may lend a scope into evaluating a possible role in Liver Cancer.
No comments:
Post a Comment