"Tong Fen Ding"with the effect of clearing away heat, dispelling wind and resolving dampness as well as promoting blood circulation, invigorating meridians and relieving arthralgia is mainly used in the treatment of gout with wind-dampness and accumulation of heat syndrome, with manifestations of fever, sweat, thirsty, anxiety, deep-colored urine, reddened tongue with yellow coating and rolling-rapid pulse. Its clinical trial, phase II was performed from February to August 1997 in Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine. The results of this clinical trial is summarized as follows

General Data
Among the 330 cases of gout in this trial group, 249 were chosen from hospitalized patients and 81 from outpatients. The former amounted to 74.45 % of the total. The ages of the patients ranged from 20-60, of these 89.52% were 40-60years. There were no significant differences between therapeutic group and control group before the treatment in the following aspects: the course of acute arthritis, the main TCM syndrome, the laboratory examination data (including blood uric acid, erythrocyte sedimentation rate, leukocyte count etc. ), the score of function of joints and the indexes of blood lipids.

Criteria of Case Selection
1. Criteria of diagnosis of primary gout in western medicine
Age, case history, predisposing factor, symptoms and physical and biochemical diagnostic indexes were coincidence with diagnostic criteria of gout
2. Grading of joint function
Grade I: No restriction in activities; Grade II: moderate restriction in activities; though restricted in one or more joints but still could do or daily activities; Grade III: marked restriction in activity, could only take care for themselves of daily life; Grade IV: sitting or lying on bed only.
3. Syndrome differentiation in traditional Chinese medicine
Wind-dampness and accumulation of heat syndrome: characterized by joint swelling, redness, heat and pain, with acute onset, fever, sweat, anxiety, deep-colored urine, reddened tongue with yellow coating and rolling-rapid pulse.

Therapeutic Methods
Therapeutic group: Oral administration of “Tong Feng Ding"capsule, each capsule contains 0. 4g of the medicine, 4 capsules each time, 3 times a day, for one month. Control group: Taking Tongfenglixian tablet (produced by Hoffman Pharmaceutical Factory, Germany) one tablet daily, for one month.
All other medicines were suspended in both groups, with 1 month constituting a therapeutic course

Result
1. Criteria of evaluation
l). Therapeutic effects on acute gouty arthritis
Marked Effectiveness: functions of joints become normal or basically restored, main laboratory examination indexes are normal or basically normal.
Effectiveness: main function of joints and main laboratory indexes improved Ineffectiveness: no improvement at all after the treatment.
2). Effectiveness of symptoms and signs
Marked Effectiveness: symptom severity scores after the treatment reduced to less than or equal to 1/3 of that before the treatment.
Effectiveness: symptom severity scores after the treatment reduced to around 1/3-2/3 of that before the treatment.
Ineffectiveness: Symptom severity scores after the treatment reduced to more than2/3 of that before the treatment.
2. Comparison of the therapeutic effects on acute gouty arthritis in the two groups (see Table l).
RIDIT analysis of curative effects of both groups: therapeutic group R= 0.4952, control group R= 0.5085, u = 0.40, P>0.05, no significant difference, showing that the curative effects in the two groups are similar.
3. Comparison of the therapeutic effects on TCM syndrome in the two groups (see Table 2).
RIDIT analysis of curative effects of the two groups: therapeutic group R = 0. 4908, control group R = 0' 5162, u = 0' 77, p>0.05, no significant difference. It shows that the curative effects on TCM syndrome in both groups are similar.
4. Comparison of TCM symptoms and western medicine signs in both groups (see Table 3).
The data above show: symptoms and signs of traditional Chinese medicine in either group improved markedly. The comparison of the sum of scores of symptoms and sign and average of difference in values before and after the treatment indicate that there is no statistic significant difference.

Curative Effects in Relation to Laboratory Indexes.
Comparison of the changes of laboratory indexes of patients in the two groups before and after the treatment showed that “Tong Feng Ding"has the effects of reducing blood uric acid, erythrocyte sedimentation rate and leukocyte count and also has the effects of regulating blood lipids (cholesterol, triglyceride, HDL lipoproteins) .The reducing effect on blood uric acid is similar to that of the control group.

Adverse Effects
Liver function test, kidney function test and routine blood tests were performed for the 210 patients cases in therapeutic group before and after the treatment. The results showed that no side effects of “Ton Feng Ding"has been found.

Discussion
The results of clinical trial of “Tong Feng Ding"in the treatment of 330 cases of gout (acute arthritis stage) of wind-dampness and heat accumulation syndrome show: the marked effective rate on acute gouty arthritis is 72. 38%, the effective rate is 94. 76 %; as to the curative effects on wind-dampness and heat accumulation syndrome, the markedly effective rate is 79. 05 %, effective rate is 97. 14%. The curative effects on acute gouty arthritis and symptoms and signs of traditional Chinese medicine in therapeutic group are similar to those of the control group has fairly good curative effects on symptoms and signs of traditional Chinese medicine, such as heat, redness, swelling and pain of joints, fever, fatigue, headache, anorexia, worry, thirsty, deep-colored urine, reddened tongue with yellow coating and rolling-rapid pulse etc. especially on relieving of arthralgia is excellent and the analgesic effect is similar to that of the control group. It also showed that the capsule has the actions of lowering the level of blood uric acid, reducing the erythrocyte sedimentation rate and leukocyte count and quite good effect on the regulation of blood lipids. Its reducing effect on blood uric acid is similar to that of control group.
“Tong Feng Ding"as a kind of new Chinese herbal medicine compound in the treatment of gout of wind-dampness and heat accumulation syndrome, with the effects of clearing away heat, dispelling wind and removing dampness as well as promoting blood circulation, invigorating meridians and relieving arthralgia, has definite efficacy and no side effects. It is convenient in clinical use and easily accepted by patients of gout, thus it would be widely used.
　　
Table 1.

Table 2.

Table 3