Efficacy and Safety of Sahastara Remedy Extract Capsule in Primary Knee Osteoarthritis: A Randomized Double-Blinded Active-Controlled Trial
Table 5
Effect of SHT and diclofenac on blood pressure, renal functions, liver functions and blood chemistry.
Data
Follow-up
Treatment
value
Sahastara (n = 32)
Diclofenac (n = 31)
Blood pressure
Systolic (normal< 140 mmHg)
Day 0
128.39 (8.43)
129.55 (7.57)
0.57m
Day 14
127.36 (7.63)
130.94 (8.32)†
0.66m
Day 28
127.31 (7.32)
131.71 (8.09)††
0.01m
Diastolic (normal 90 mmHg)
Day 0
80.45 (7.25)
81.21 (6.88)
0.67m
Day 14
80.45 (5.06)
81.81 (6.96)
0.38m
Day 28
79.19 (5.01)
80.52 (7.40)†
0.02m
Renal functions
Blood urea nitrogen, BUN (mg/dL) (normal range = 7.0–18.0)
Day 0
14.89 (4.3)
14.41 (5.87)
0.27m
Day 14
16.68 (5.76)
14.97 (4.11)
0.40m
Day 28
15.19 (3.90)
15.38 (5.00)
0.91m
Creatinine (normal range = 0.8–1.3)
Day 0
0.74 (0.12)
0.72 (0.22)
0.14m
Day 14
0.76 (0.13)
0.75 (0.12)
0.41m
Day 28
0.74 (0.15)
0.94 (1.11)
0.45m
Liver function tests
AST (U/L) (normal range = 15–37U/L)
Day 0
24.71 (6.56)
24.03 (6.53)
0.55m
Day 14
26.75 (10.88)
28.25 (7.7)
0.11m
Day 28
27.59 (9.39)
29.74 (11.33)†
0.48m
ALT (U/L) (normal range = 30–65U/L)
Day 0
32.18 (9.55)
28.55 (8.4)
0.86m
Day 14
35.56 (15.39)
34.06 (11.59)†
0.93m
Day 28
33.87 (15.81
38.61 (20.15)†
0.25m
ALP (U/L) (normal range = 30–120U/L)
Day 0
74.27 (20.18)
78.96 (22.18)
0.59m
Day 14
75.66 (18.22)
80.54 (18.24)
0.21m
Day 28
76.09 (19.19)
82.00 (19.61)
0.19m
The result of another laboratory
FBS (74–106 mg/dL)
Day 0
104.606 (27.06)
116.48 (61.15)
0.59m
Day 14
105.96 (29.34)
114.18 (62.12)
0.39m
Day 28
104.65 (29.41)
113.58 (54.26)
0.73m
HDL-cholesterol (40–60 mg/dL)
Day 0
55.66 (15.18)
58.00 (14.31)
0.48m
Day 14
55.90 (15.51)
57.31 (15.55)
0.71m
Day 28
57.28 (13.58)
53.70 (16.09)
0.52m
Total cholesterol (40–60 mg/dL)
Day 0
220.63 (40.34)
222.03 (44.27)
0.85m
Day 14
214.35 (35.12)
220.65 (38.35)
0.37m
Day 28
212.00 (37.78)
224.51 (41.71)
0.18m
LDL-cholesterol (0–150 mg/dL)
Day 0
133.39 (34.47)
132.63 (40.85)
0.82m
Day 14
130.27 (32.02)
132.00 (32.00)
0.74m
Day 28
130.25 (30.02)
132.54 (36.00)
0.76m
Triglyceride (0–150 mg/dL)
Day 0
152.66 (98.81)
144.64 (79.68)
0.98m
Day 14
159.90 (114.84)
145.13 (85.90)
0.84m
Day 28
135.09 (84.13)
158.68 (16.47)
0.53m
Live function total protein (6.4–8.2 mg/dL)
Day 0
4.60 (3.98)
3.93 (0.25)
0.44m
Day 14
4.30 (3.80)
3.75 (0.34)
0.44m
Day 28
4.20 (3.80)
3.76 (0.28)
0.24m
Albumin (3.4–5 mg/dL)
Day 0
3.98 (0.25)
3.93 (0.25)
0.51m
Day 14
3.80 (0.27)
3.75 (0.34)
0.66m
Day 28
3.80 (0.20)
3.76 (45 .28)
0.54m
Globulin (1.5–3.5 mg/dL)
Day 0
3.70 (0.30)
3.85 (0.47)
0.51m
Day 14
3.65 (0.35)
3.76 (0.51)
0.66m
Day 28
3.56 (0.28)
3.73 (0.48)
0.54m
Total bilirubin (0.2–1.0 mg/dL)
Day 0
0.63 (0.37)
0.53 (0.28)
0.11m
Day 14
0.53 (0.34)
0.43 (0.16)
0.25m
Day 28
0.52 (0.23)
0.47 (0.21)
0.13m
Direct bilirubin (0.0–0.2 mg/dL)
Day 0
0.13 (0.07)
0.14 (0.12)
0.87m
Day 14
0.11 (0.05)
0.10 (0.03)
0.30m
Day 28
0.10 (0.04)
0.10 (0.04)
0.75m
Total alkaline phosphatase (50–136 U/L)
Day 0
74.27 (20.18)
78.96 (22.18)
0.59m
Day 14
75.66 (18.22)
80.54 (18.24)
0.21m
Day 28
76.09 (19.19)
82.00 (19.61)
0.19m
CBC WBC (4.9–11.0 K/cumm)
Day 0
6.37 (1.42)
6.25 (1.67)
0.68m
Day 14
5.83 (1.88)
5.77 (1.75)
0.92m
Day 28
6.09 (1.43)
5.98 (1.57)
0.81m
Neutrophil (45–75%)
Day 0
52.45 (12.26)
52.45 (12.26)
0.40m
Day 14
51.15 (9.11)
51.15 (9.11)
0.35m
Day 28
52.00 (6.99)
52.00 (6.99)
0.39m
Lymphocyte (20–45%)
Day 0
37.93 (8.27)
37.93 (8.27)
0.54m
Day 14
39.54 (8.341)
39.54 (8.34)
0.62m
Day 28
37.66 (6.84)
37.66 (6.84)
0.74m
Monocyte (2–10%)
Day 0
3.52 (01.58)
3.55 (01.64)
1.00m
Day 14
3.69 (01.9)
3.59 (01.67)
0.99m
Day 28
3.70 (01.52)
3.48 (02.09)
0.18m
Eosinophil (4–6%)
Day 0
4.14 (3.47)
4.16 (4.04)
0.74m
Day 14
4.26 (2.41)
4.97 (3.87)
0.70m
Day 28
4.83 (2.48)
6.22 (4.43)
0.18m
Basophil (0-1%)
Day 0
0.53 (0.25)
0.57 (0.75)
0.33m
Day 14
0.71 (01.17)
0.49 (0.44)
0.30m
Day 28
0.47 (0.24)
0.42 (0.22)
0.62m
RBC (4.5–6.0 × 106/cumm)
Day 0
4.40 (0.36)
4.36 (0.59)
0.25m
Day 14
4.27 (0.65)
4.34 (0.63)
0.73m
Day 28
4.32 (0.40)
4.48 (1.10)
0.99m
Hb (14–18 gm/dL)
Day 0
12.4 (0.98)
14.82 (17.60)
0.03m
Day 14
12.14 (0.92)
11.66 (1.12)
0.14m
Day 28
12.01 (1.00)
11.71 (1.13)
0.33m
Hct (41–51%)
Day 0
37.20 (2.42)
35.58 (3.08)
0.36m
Day 14
36.92 (2.41)
35.81 (3.52)
0.35m
Day 28
36.63 (3.08)
35.60 (3.50)
0.20m
Platelets (150–400 K/cumm)
Day 0
275.60 (58.63)
284.06 (78.23)
0.99m
Day 14
286.90 (63.08)
283.87 (67.26)
0.61m
Day 28
288.00 (64.26)
290.21 (68.90)
0.99m
Data represent mean (SD); ∗∗statistical analysis; mMann–Whitney U test. For all within group statistical analysis: repeated measure ANOVA. †Significant difference from day 0 within the group ();††significant difference from day 0 within the group ().
