Introduction of the Tangcao tablet
【Drug Name】
Trade Name：Tangcao tablet
Chinese Pinyin: Tangcao Pian
【Main Ingrendients】
Geranium herb、 honeysuckle flower、 Pericarpium Trichosanthis、 bupleurum root、 haichow elsholtzia herb、 milkvetch root、 licorice root、flower of silk cotton、caulis millettiae、 orizae、radix、Solanum nigrum、Hedyotic diffusa and etc.
【Discription】
The product is a thin film coated tablet which contains a brown core with dedicate fragrance and astringent taste.
【Functions and indications】
Eliminate heat and toxin from the blood , activate blood circulation and nourishi Qi. Used for hiv-infector and AIDS patients (100-400cells/ mm3 of CD4 lymphocytes). The product can Increase CD4 cell count and ameliorate the symptoms of diarrhea, fatigue, alopecia and poor appetite as well as the motion function.
【Specification】
0.4g per tablet.
【Usage and dosage】
Take 8 tablets each time, 3 times per day, or take 8-10 tablets each time, 2 times per day, 6 months for one treament.
【Adverse reactions】
Possible adverse reacitons could be nausea, dyspepsia and insomnia. Usually these symptoms relieve spontaneouslly and no drug withdrawal is needed.
【Restrictions on Use】
Not clear.
【Precautions】
1. Avoid raw, cold or spicy food druing treatment period.
2. Avoid alcoholic beverages during treatment period.
3. The product should be used under supervision of a physician when applied to patients in acute infective stage, or patients with serious opportunistic infection, opportunistic tumor, allergic physical constitution or patients suffering serious psychotic disorder or neuropathic dissease.
4. Cautions should be exercised in the cases of children, senior citizens, pregnant or lactating women due to lack of clinical study.
【Clinical trial】
Randomized controlled double-blind multicentric clinical study was carried out to evaluate the efficacy and safety of Tangcao tablet for HIV/AIDS treatment. The following were the results.
1.Absolute CD4 cell count:
After a treatment course of 6 month, a remarkable raise of CD4 cell count was observed in the Tangcao tablet treatment group, while in the placebo group CD4 cell count decreased. Statistical significance was found between the two groups. Further data analysis showed in ITT(intent to treatment) population, the average of CD4 cell count of treatment group increased by 69.32cells/ml, while in placebo group the number droped down by 24.56cells/ml. For PP(per-protocol) population, the average of CD4 cell count of treatment group increased by 71.64cells/ml, while in placebo group the number decreased by 37.38cells/ml. The results above showed an obvious advantage of Tangcao tablet over placebo.
Among ITT population 50.57% patients in treatment group was seen a more than 30% raise of CD4 cell count, which means the effective rate is 50.57％; For PP population, the number is 51.81%. Again the advantage of Tangcao tablet over placebo was obvious. According to the center-layered CMH test, difference between two groups has statistical significance（P=0.000）, the conclusions were the same when considering ITT and PP population respectively.
The efficacy of Tangcao tablet was evaluated at the end of treatment course with CD4 cell count as index, HIV-infectors and AIDS patients were analyzed respectively: For the HIV-infectors, the total effective rate of the treatment was much higher than that of the placebo. Center-layered CMH test showed a difference of CD4 cell count between the Tangcao tablet group and the placebo group（PITT =0.00）, and the results from ITT and PP population were consistent. For the AIDS patients, the total effective rate of the treatment was much higher than that of the placebo. Center-layered CMH test showed a statistically significant difference of CD4 cell count between the Tangcao tablet group and the placebo group（Ppp =0.011）, and the results from ITT and PP population were consistent.
2. HIV virus load (log)
After a treatment course of 6 month, patients in the Tangcao tablet group maintained virus load, while patients in placebo group experienced virus load increasement. The change of virus load before and after treatment was statistically significant（PITT =0.005, Ppp=0.000）. For ITT population, virus load in the Tangcao tablet group declined 0.05, while in placebo group it increased 0.21. For PP population, virus load in the Tangcao tablet group declined 0.05, while in placebo group it increased 0.29. Covariance analysis showed no statistical significance (PITT=0.303; Ppp=0.121) as far as interaction between centers and treatment groups was considered, which indicated clinical results from all the centers were consistent.
Statistical analysises were also conducted for HIV-infectorss and AIDS patients respectively: For HIV-infectors, difference of the virus load between of two groups was observed statistically significant (PITT=0.037); For AIDS patients, statistical significance was also observed as to difference of the virus load (PITT=0.005). The advantage of Tangcao tablet over the placebo was obvious in both case.
3. Clinical Symptom Score
Clinical trials observed remarkable improvement on clinical symptoms such as diarrhea, fatigue, alopecia and poor appetite as well as amelioration on motion function. The improvement was found statistically significant between treatment group and placebo group(P=0.000). The advantage of Tangcao tablet over the placebo was obvious with respect to total clinical score, individual clinical score, and body weight.
4. Ratio between CD4 and CD8
The ratio of CD4 to CD8 was increased in the Tangcao tablet group while placebo group saw a decrease of the ratio. Calculation based on covariance analytical model indicated the difference statistically significantly between Tangcao tablet group and placebo group.
5. CD8 cell count
No statistical significance was found between the two groups.
6.Safety
Slight side effects occurred in isolated cases, including slight nausea, indigestion and slight insomnia. These unwanted symptoms disappeared soon without intervention and no treatment was interupted.
No adverse reaction against liver, kidney, heart and hematological system was observed after administration of Tangcao tablet for 6 months. The Tangcao tablet was well tolerable and no drug withdrawal was seen because of adverse reactions.
【Pharmacology and Toxicity】
In clinical trials Tangcao tablet is shown to be highly effective in inhibiting HIV and HCV replication in AIDS patients co-infected with HCV. Other effects exibited include decreasing β2 microglobulin in peripheral blood of HIV-infectors, promoting sceretion of Th1 cytokine and enhancing T cell function, which is favorable for virus replication control. Virus replication inhibition is observed in in vitro test as well.
【Storage】
Store in a dry place at a temperature below 20℃, keep away from light.
【Package】
Plastic bottle containing 100 tablets.
【Validity 】
36 months.
【Executive Standard 】
Drug Standards of China(Approved New Drug) YBZ02562004-2008Z
【Licence number】
H.M.L.N. Z20050291
