Volume. 1, July - September, 2012 - amam-ayurveda.org

4.2.7. Effect of trial drug on normal cycle duration & bleeding days
with heavy flow (n=8):
Among the subjects with heavy flow (under normal duration of cycle and
bleeding days), only one subject showed improvement by the 3rd cycle
(P>0.05).
Table 9: Efficacy of trial drug in amount of flow
N=8 Baseline Cycle 1 Cycle 2 Cycle 3 Cycle 4
H 4 3 3 3 2
M 4 5 5 5 6
S 0 0 0 0 0
4.2.8. Efficacy of trial drug on number of pads (normal duration of
cycles (n=8):
Subjects with moderate flow have been documented using a range of 18 to
35 pads per cycle. All the subjects were having almost normal pads usage
at the baseline (mean = 30.3) and at the end of the study (mean= 19.67).
Table 10: Effect of trial drug on number of pads
No. of
pads
Cycles
Baseline Cycle 1 Cycle 2 Cycle 3 Cycle 4
30.3 23.25 25.44 21.63 19.67
No Adverse Drug Reactions were reported / documented with any of the
subjects with the trial drug. No patient is withdrawn from the study due to
reactions related to study drug or due to any other adverse event.
5. SUMMARISED STUDY AND CONCLUSION:
• 44 female subjects suffering from menstrual irregularities with
the mean age of 23 years (+ 4.04) have been administered with
WHS/2004/02 (DRF/AY/4007) orally at a dose of 10 ml twice daily
for 120 days.
• 22 out of 26 (84.62%) with increased duration of cycles showed
mean reduction of 15.7 days from baseline. The cycle duration was
reduced from 46.15 days to 30.45 days (P