scholarly journals Mig-RL: a Natural Preventive Treatment Against Migraine. Outcomes of a Randomized, Double-Blind Clinical Trial

2021 ◽  
Vol 8 (7) ◽  
pp. 01-09
Author(s):  
Rémi Shrivastava
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Plant Extracts ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Salix Alba ◽  
Double Blind ◽  
Tanacetum Parthenium ◽  
Double Blind Clinical Trial ◽  
The Mean

BACKGROUND The efficacy and safety of Mig-RL (Commercial name HERBA MIG), a synergistic association of two plant extracts, Tanacetum parthenium (150mg, 0.5% parthenolide) and Salix Alba (150mg, 25% salicin) were investigated as a preventive treatment for episodic migraine. Mig-RL was compared with a placebo in a randomized, double-blind clinical trial. MATERIALS AND METHODS This trial included 129 patients having episodic migraine and diagnosed with migraines without aura for over a year and meeting the migraine criteria, as defined in the International Classification of Headache Disorder (ICHD-3 :1.1). P). Baseline data was collected for 28 days before the start of the three-months treatment period. Patients were randomized in a 1:1 ratio to receive either Mig-RL (a single dose of 300mg per day, per os) or placebo (identical capsules containing 300 mg starch, 1 per day, per os) for a period of 12 consecutive weeks. The primary endpoint was the mean change in the average number of migraine days per month, comparing the baseline 28-days pre-intervention period with the weeks 9 to 12 after the first dose of the trial regimen. Secondary endpoints were the percentage of patients with a reduction of at least 30% in the average number of migraine days per month and days of use of any acute headache medication per month. The HIT-6 and MIDAS scores were also evaluated vs. baseline between the two groups. RESULTS Out of 172 patients enrolled, 129 were randomly assigned to the Mig-RL arm (n=65) or the placebo arm (n=64). The mean (±SD) number of baseline migraine days per month was 8.4±1.9 and 8.7±1.9, respectively. The mean reduction in the average number of migraine days per month was 2.5±0.4 (p<0.001) with Mig-RL and 1.9±0.4 (p<0.001) with placebo. A difference of 0.6±0.4 (p=0.01) between the two groups. The percentage of patients with at least 30% reduction in average number of migraine days per month was 49% in Mig-RL and 32% in placebo (p<0.05 vs. placebo). Only a few isolated and minor side effects were reported and overall Mig-RL was well tolerated by patients. CONCLUSIONS Mig-RL, a synergistic combination of two plant extracts, seems to have a moderate effect in the prevention of migraines. Without side effects, the combination of Tanacetum parthenium and Salix alba could be an additional help for some patients. However, further investigations and an improvement in the quality of the plants are still necessary.

Preventive Treatment of Migraine Headache with a New Isoergolenyl Derivative

1978 ◽  
Vol 6 (6) ◽  
pp. 476-482 ◽  
Author(s):  
W M Herrmann ◽  
M Krištof ◽  
M Sastre y Hernandez
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Migraine Headache ◽  
Preventive Treatment ◽  
Double Blind ◽  
Good Tolerance ◽  
Dopaminergic Activity ◽  
Double Blind Clinical Trial ◽  
Term Administration

In the present double-blind clinical trial an isoergolenyl derivative with periphal antiserotonin, central dopaminergic activity and a-increasing effect on the human EEG, lisuride hydrogen maleate, was tested against placebo in a six-month trial involving 240 patients. Lisuride in long-term administration significantly reduces the frequency of migraine attacks in comparison to placebo. Its advantages are good tolerance and minimal side-effects. It is therefore concluded that lisuride is a suitable and effective drug for the prevention of migraine.

scholarly journals Comparing the Efficacy of Topical Metformin and Placebo in the Treatment of Melasma: A Randomized, Double-blind, Clinical Trial

2019 ◽  
pp. 1-8
Author(s):  
Mohammad Ali Mapar ◽  
Ali Asghar Hemmati ◽  
Ghazal Namdari
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Double Blind ◽  
Laboratory Findings ◽  
Double Blind Clinical Trial ◽  
Metformin Group ◽  
Significant Difference ◽  
Before And After ◽  
P 16 ◽  
The Mean

Introduction: Generally affecting women, melasma is the acquired disorder of hyperpigmentation, and researches are still ongoing to find an effective, fast, and low-side-effect drug treating this disease. The present study is aimed at comparing the efficacy of topical metformin and placebo in the treatment of melasma. Methods: Sixty patients with melasma were treated in placebo and topical metformin recipient groups in a double-blind clinical trial. In addition to the demographic and laboratory findings of patients before and after the intervention, the MASI Score of patients in weeks 0, 4, 8, and 12 of the study and then one month after the study were analyzed using SPSS version 20 software. Results: The mean age of the studied patients was 35.25 ± 7.11 years. No significant difference was observed between the phenotypes (P= .49) and the type of melasma (P= .63) in the two groups. The mean MASI score of patients at the time of being included in the study in the placebo group was 10.47 ± 3.08; and in the metformin group, it was 11.93 ± 4.64 (P = .16). Compared to the beginning of the study, the MASI scores were significantly decreased in both groups of placebo (P = .00) and metformin (P = .00) one month after the end of the study; nevertheless, no statistically significant difference was observed between the MASI Scores of two groups in any of the study periods (P > .05). Conclusion: The results of the present study showed that metformin cream significantly declines the patients’ MASI score and does not have any effect on patients’ laboratory markers. Of course, no significant difference was observed between the MASI scores of the patients receiving metformin and the placebo group; however, the MASI score decrease trend continued until the 12th week; while in the placebo group, no significant decrease was seen after eight weeks.

scholarly journals Comparison the Efficacy of Intranasal Ketamine Versus Intravenous Ketorolac on Acute Non-Traumatic Headaches: A Randomized Double-Blind Clinical Trial

2020 ◽  
Author(s):  
Houman Rafiee Sarvari ◽  
Hamidreza Baigrezaii ◽  
Mohammad Nazarianpirdosti ◽  
Amirhossein Meysami ◽  
Roya Safari-Faramani
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Double Blind ◽  
Analgesic Effects ◽  
Headache Severity ◽  
Selective Approach ◽  
Double Blind Clinical Trial ◽  
Group B ◽  
Short Time ◽  
Intravenous Ketorolac

Abstract Introduction: Non - traumatic headaches are one of the most common causes of referral to hospital emergency. This study aimed to compare the efficacy of intranasal ketamine and intravenous ketorolac on acute non-traumatic headaches.Methods: This randomized and double-blind clinical trial in 2019 years. 140 people were randomly divided into intranasal ketamine (A) and intravenous ketorolac (B). Group (A) received ketamine intranasal (0.75 mg/kg, max 75mg), and group B received intravenous ketorolac (30 mg). Headache severity was measured on arrival, 30, 60, and 120 minutes after intervention with Visual Analogue Scale (VAS). The side effects were recorded an hour after the intervention.Result: The mean difference of pain intensity 30, 60, and 120 minutes after the intervention between the two groups were statistically significant (p<0.001). In the first 30 minutes, significant changes were observed in the VAS levels of the two groups. These changes were more and significant in the intranasal ketamine group (p <0.001). Side effects such as fatigue, dizziness, public discomfort, nausea, increased heart rate, and hypertension were significantly higher in the ketamine group (p <0.05).Conclusion: Intranasal ketamine and intravenous ketorolac both effectively reduced headaches. However, more analgesic effects of intranasal ketamine in a short time can be considered as a selective approach to reducing headaches.

scholarly journals Comparison the Efficacy of Intranasal Ketamine Versus Intravenous Ketorolac on Acute Non-traumatic Headaches: A Randomized Double-Blind Clinical Trial

2020 ◽  
Author(s):  
Houman Rafiee Sarvari ◽  
Hamidreza Baigrezaii ◽  
Mohammad Nazarianpirdosti ◽  
Amirhossein Meysami ◽  
Roya Safari-Faramani
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Double Blind ◽  
Analgesic Effects ◽  
Headache Severity ◽  
Selective Approach ◽  
Double Blind Clinical Trial ◽  
Group B ◽  
Short Time ◽  
Intravenous Ketorolac

Abstract Introduction: Non - traumatic headaches are one of the most common causes of referral to hospital emergency. This study aimed to compare the efficacy of intranasal ketamine and intravenous ketorolac on acute non-traumatic headaches.Methods: This randomized and double-blind clinical trial in 2019 years. 140 people were randomly divided into intranasal ketamine (A) and intravenous ketorolac (B). Group (A) received ketamine intranasal (0.75 mg/kg, max 75mg), and group B received intravenous ketorolac (30 mg). Headache severity was measured on arrival, 30, 60, and 120 minutes after intervention with Visual Analogue Scale (VAS). The side effects were recorded an hour after the intervention.Result: The mean difference of pain intensity 30, 60, and 120 minutes after the intervention between the two groups were statistically significant (p<0.001). In the first 30 minutes, significant changes were observed in the VAS levels of the two groups. These changes were more and significant in the intranasal ketamine group (p <0.001). Side effects such as fatigue, dizziness, public discomfort, nausea, increased heart rate, and hypertension were significantly higher in the ketamine group (p <0.05).Conclusion: Intranasal ketamine and intravenous ketorolac both effectively reduced headaches. However, more analgesic effects of intranasal ketamine in a short time can be considered as a selective approach to reducing headaches.Trial registration: IRCT20180108038276N3, Registered 29 September 2019.

Comparison of the Analgesic Effect of Intravenous Ketamine versus Intravenous Morphine in Reducing Pain of Renal Colic Patients: Double-Blind Clinical Trial Study

2019 ◽  
Vol 14 (4) ◽  
pp. 280-285 ◽  
Author(s):  
Arash Forouzan ◽  
Kambiz Masoumi ◽  
Hassan Motamed ◽  
Seyed Reza Naji Esfahani ◽  
Ali Delirrooyfard
Keyword(s):  
Clinical Trial ◽  
Renal Colic ◽  
Initial Result ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Intravenous Morphine ◽  
Hospital Patients ◽  
The Mean ◽  
Intravenous Ketamine

Background: The effective relief of renal colic patients with low complications is one of the important concerns of emergency physicians. The aim of this study was to investigate the use of injectable ketamine as an alternative to routine drugs in the relief of pain in patients with renal colic. Methods: This double-blind clinical trial was conducted on patients who had suffered kidney pain due to kidney stones in 2017, referred to Ahvaz Imam Khomeini Hospital. Patients were divided into 2 groups: the first group received intravenous ketamine (0.3 mg/kg) and the second group received intravenous morphine (0.1 mg/kg) in a double-blind form. Finally, the mean pain was evaluated before injection, after 10, 20, 30, and 60 minutes as the initial result while the side effects were considered as secondary results. Results: In this study, 135 patients with renal colic participate in this study. The mean pain at the time of referral to the hospital in the group receiving morphine and ketamine was 9.2 and 9.2, respectively, which did not show any significant difference. Based on these findings, there was no significant difference between the factors evaluated during the study of the two groups. Only in the ketamine group, there were 3 cases of nausea and 1 of vomiting. However, there was a significant increase in the need for additional doses of fentanyl in the morphine recipient group (p = 0.02). Conclusion: The findings suggest that the use of ketamine can produce a more rapid relief effect, and decrease the use of opioids which create various complications, including nausea and vomiting in patients, especially patients with renal colic.

A Long Term Double-Blind Clinical Trial of Ibuprofen and Indomethacin in Rheumatoid Arthritis

1975 ◽  
Vol 3 (3) ◽  
pp. 158-171 ◽  
Author(s):  
G L Royer ◽  
T E Moxley ◽  
M S Hearron ◽  
A Miyara ◽  
B M Shenker
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trial ◽  
Side Effects ◽  
Double Blind ◽  
Double Blind Clinical Trial

Two-hundred and eighteen individuals with rheumatoid arthritis were randomly assigned to six months treatment with ibuprofen (900-1800 mg/day) or indomethacin (75-150 mg/day). The drugs were equally effective in the treatment of rheumatoid arthritis while the incidence of indomethacin side-effects was 1·5 times greater than the incidence of ibuprofen side-effects.

scholarly journals Treatment of patients with Schistosomiasis mansoni: a double blind clinical trial comparing praziquantel with oxamniquine

1986 ◽  
Vol 28 (3) ◽  
pp. 174-180 ◽  
Author(s):  
Luiz Caetano da Silva ◽  
José Murilo R. Zeitune ◽  
Lucia Maria F. Rosa-Eid ◽  
Dirce Mary C. Lima ◽  
Rita H. Antonelli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Statistical Significance ◽  
Double Blind ◽  
Chemical Structures ◽  
Double Blind Clinical Trial ◽  
Negative Findings ◽  
Rectal Biopsies ◽  
Cure Rates

A double-blind clinical trial involving 120 patients with chronic schistosomiasis was carried out to compare the tolerability and efficacy of praziquantel and oxamniquine. The patients were randomly allocated into two groups. One was treated with praziquantel, 55 mg/kg of body weight CBWT), and the other one with oxamniquine, 15mg/kg bwt, administered in a single oral dose. The diagnosis and the parasitological follow-up was based on stool examinations by quantitative Kato-Katz method and on rectal biopsies. Side-effects — mainly dizziness, sleepness, abdominal distress, headache, nausea and diarrhea — were observed in 87% of the cases. Their incidence, intensity and duration were similar for both drugs but abdominal pain was significantly more frequent after praziquantel intake and severe dizziness was more commonly reported after oxamniquine. A significant increase of alanine-aminotransferase and y-glutamyltransferase was found with the latter drug and of total bilirubin with the former one. A total of 48 patients treated with praziquantel and 46 with oxamniquine completed with negative findings the required three post-treatment parasitological controls — three slides of each stool sample on the first, third and sixth month. The achieved cure rates were 79.2% and 84.8%, respectively, a difference without statistical significance. The non-cured cases showed a mean reduction in the number of eggs per gram of feces of 93.5% after praziquantel and of 84.1% after oxamniquine. This diference also was not significant. Five patients retreated with praziquantel were cured but only one out of three treated a second time with oxamniquine. These findings show that both drugs — despite their different chemical structures, pharmacological properties and mechanisms-of-action — induce similar side-effects as well as a comparable therapeutical efficacy, in agreement with the results reported from analogous investigations.

scholarly journals Evaluation of the efficacy of a topical chamomile-pumpkin oleogel for the treatment of plaque psoriasis: an intra-patient, double-blind, randomized clinical trial

2018 ◽  
Vol 5 (11) ◽  
pp. 2811-2819
Author(s):  
Sima Kolahdooz ◽  
Mehrdad Karimi ◽  
Nafiseh Esmaili ◽  
Arman Zargaran ◽  
Gholamreza Kordafshari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Plaque Psoriasis ◽  
Severity Index ◽  
Double Blind ◽  
The Mean ◽  
Psoriasis Severity

Background: Plaque psoriasis is a chronic inflammatory skin disease. Conventional treatments of psoriasis are not completely effective. In addition, unwanted side effects limit their long-term use. In this regard, developing new natural treatments with fewer side effects could be an alternative option. This study was designed to evaluate the efficacy and safety of topical chamomile-pumpkin oleogel (ChP) in treating plaque psoriasis. Methods: A total of 40 patients with mild-to-moderate plaque psoriasis were enrolled in this intra-patient, double-blind, block-randomized clinical trial. In each patient, bilateral symmetrical plaques were treated with ChP or placebo twice daily for four weeks. For clinical assessment, the Psoriasis Severity Index (PSI) and the Physician's Global Assessment (PGA) scale were evaluated at baseline and after the treatment. At the end of the study, patients' satisfaction with the treatment was evaluated using a visual analog scale (VAS) ranging from 0 to 10. For safety assessment, all treatment-related side effects were recorded. Results: Thirty-seven subjects (20 female, 17 male; age 20–60 years) completed the study. The mean decreases in the PSI score in the ChP group (4.09 +/- 2.24) were significantly (p = 0.000) greater than the placebo group (0.48 +/- 1.39). According to the PGA results, 13/37 (35%) of the ChP-treated plaques could achieve marked to complete improvement compared to 0% in the placebo group. Three patients dropped out from the study due to worsening of bilateral plaques during the first week of trial. Conclusion: Our results suggest that topically applied ChP could provide a safe and effective complementary option for psoriasis plaque management. IRCT registration code: IRCT2016092830030N1.  

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