by Forest Raga March 4, 2021
The present study was carried out to investigate the efficacy and safety of the Effects of Chlorophytum borivilianum (Krishna Musli root) on physical performance
OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum(CB) on physical performance when exposed to accustomed activity (AA) and unaccustomed activity (UA) and the effect of CB on heart rate (HR) and blood pressure (BP) in the presence of UA and the effect on muscle strength in comparison with placebo.
Treatment Offered
This was an investigator-initiated, pilot study, designed as a prospective, randomized, placebo-controlled, double-blind, two-arm comparative study in healthy adult volunteers with the fixed-dosage regimen. Institutional Ethics Committee approval (EC/89/2016) was taken before conducting the study, and it has been registered on the Clinical Trial Registry of India (CTRI/2017/08/009586).
Volunteers were informed about the study by word of mouth, and those who were coming to the institute on a daily basis were recruited in the study. Volunteers who fulfilled the eligibility criteria (male/female between the age groups of 18 and 45 years, normal hematological and biochemical investigations, and not performing any strenuous activity) were included in the study. Those with a history of allergy or intolerance to study drug, addiction, lower- or upper-limb injury, and already taking other Rasayana herbs, pregnant/lactating women, and those with other serious disorder or if volunteers did walk continuously >1 has a part of exercise regimen were excluded from the study.
The standardized powder form of the root of CB was used. Maize starch powder was used as a placebo. The dose of the study drug and placebo was 3 g/day. The dose of the drug was selected from standard ayurvedic textbooks. Both study drugs and placebo were given in a capsule form orally. Each capsule containing 500 mg of the drug was given as two capsules three times a day (TDS) after a meal for 60 days.
Since the study was double-blind (the outcome assessor and volunteers were blinded), capsules of both study drug and placebo were of the same size and color (dark orange), and these drugs were dispensed by the investigator who generated the randomization codes.
Volunteers were informed about the study by word of mouth, and those who were coming to the institute on a daily basis were recruited in the study. Volunteers who fulfilled the eligibility criteria (male/female between the age groups of 18 and 45 years, normal hematological and biochemical investigations, and not performing any strenuous activity) were included in the study. Those with a history of allergy or intolerance to study drug, addiction, lower- or upper-limb injury, and already taking other Rasayana herbs, pregnant/lactating women, and those with other serious disorder or if volunteers did walk continuously >1 has a part of exercise regimen were excluded from the study.
The standardized powder form of the root of CB was used. Maize starch powder was used as a placebo. The dose of the study drug and placebo was 3 g/day. The dose of the drug was selected from standard ayurvedic textbooks. Both study drugs and placebo were given in a capsule form orally. Each capsule containing 500 mg of the drug was given as two capsules three times a day (TDS) after a meal for 60 days.
Since the study was double-blind (the outcome assessor and volunteers were blinded), capsules of both study drug and placebo were of the same size and color (dark orange), and these drugs were dispensed by the investigator who generated the randomization codes.
Sixty volunteers were recruited after taking an audiovisual written informed consent. Volunteers were checked for healthy status by clinical history, examination, complete blood count, fasting blood sugar levels, liver function test, and renal function test.
After screening, they were randomized using online software into two groups, i.e., 30 in CB and 30 in the placebo group. Randomization was done after a successful screening procedure on the baseline visit (day 0). Randomization codes were generated by the investigator who was not assessing the outcomes.
The evaluation was done on three visits: baseline visit (day 0), day 30, and day 60.
After screening, they were randomized using online software into two groups, i.e., 30 in CB and 30 in the placebo group. Randomization was done after a successful screening procedure on the baseline visit (day 0). Randomization codes were generated by the investigator who was not assessing the outcomes.
The evaluation was done on three visits: baseline visit (day 0), day 30, and day 60.
Study drugs for the first 30 days were given to the volunteers on baseline visit, i.e., day 0, and for the next 30 days, it was given on the next visit on day 30. Compliance was assessed by counting the number of capsules in the container on day 30 and day 60. Compliance of >80% was necessary to continue the study.
All the tests were performed in an air-conditioned room (24°C€“26°C), and during each test, a rest period of 15€“20 min was given to the volunteers for the hemodynamic stabilization.
Results
The data were collected, compiled, and analyzed from May 2016 to October 2017, after executing the approved protocol in each volunteer. Sixty-seven volunteers were screened, out of which 60 healthy adult volunteers were included in the study [Figure 1]. Seven volunteers were not eligible to participate in the study. Out of 60 volunteers, 19 were female and 41 were male. These 60 volunteers were randomly divided into two groups, 30 volunteers per group. All 60 volunteers completed the study. Data were expressed as mean ± standard deviation, and P < 0.05 is considered statistically significant.
The mean age of the 60 volunteers was 28.53 ± 5.12 years (median: 27.5 years). The mean body mass index was 22.67 ± 1.80 kg/m2. Clinical examination and all the investigations were normal. Resting HR, i.e., before starting the tests, was 79.404 ± 6.62 beats/min, and systolic BP (SBP) was 118.10 ± 6.72 mmHg and diastolic BP (DBP) was 73.09 ± 7.69 mmHg.
CB, when administered daily to healthy individuals for a 2-month duration, has shown the significant change in all the variables of physical performance when exposed to AA, i.e., distance in 6MWT has increased from 431.66 ± 38 (day 0) to 468.33 ± 0.43 m on day 60 in comparison to placebo and day 0. In the same test, HR after the test decreased from 85.30 ± 9.31 to 78.30 ± 8.26 on day 60 when compared with day 0 and placebo. SBP was also decreased on day 60 in the CB group when it was compared with the placebo (P < 0.05) [Table 1].
CB, when administered daily to healthy individuals for a 2-month duration, has shown the significant change in all the variables of physical performance when exposed to AA, i.e., distance in 6MWT has increased from 431.66 ± 38 (day 0) to 468.33 ± 0.43 m on day 60 in comparison to placebo and day 0. In the same test, HR after the test decreased from 85.30 ± 9.31 to 78.30 ± 8.26 on day 60 when compared with day 0 and placebo. SBP was also decreased on day 60 in the CB group when it was compared with the placebo (P < 0.05) [Table 1].
Conclusion
We would like to conclude that CB had shown significant adaptogenic activity in the presence of AA even when it was administered for a shorter duration, i.e., for 30 days. This implies that CB has a better effect on physical performance in the presence of AA even after a short duration of administration. In the presence of UA, improvement in the physical performance was seen on day 60, which proves that CB had produced a significant effect on UA when it was administered for a longer duration. In FWT also, there was a decrease in the DBP and HR on day 60 which was statistically significant.
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