A B C D E F G H I J K L M N O P Q R S T U V W X Y Z All
Dound, Y. A.
- The Effect of Vitamin K2-7 in Peripheral Neuropathy Due to Vitamin B12 Deficiency and Diabetes Mellitus: a Preliminary Study
Authors
1 Department of Haematology, B. Y. L. Nair Ch. Hospital, Dr. A. L. Nair Road, Mumbai Central, 7, Shefalee, Makarand Society, Veer Savarkar Marg, Mahim, Mumbai - 400016, IN
2 Department of Haematology, B. Y. L. Nair Ch. Hospital, Dr. A. L. Nair Road, Mumbai Central, Mumbai, IN
3 Viridis BioPharma Pvt. Ltd., V. N. Purav Marg, Chunabhatti, Mumbai, IN
4 ICMR Advance Centre of Reverse Pharmacology in Traditional Medicine, Medical Research Center-Kasturba Health Society, Mumbai, IN
Source
The Indian Practitioner, Vol 66, No 10 (2013), Pagination: 625-629Abstract
Objective: To evaluate the activity and tolerability of Vitamin K2-7 (MK-7) in a series of patients with peripheral neuropathy due to vitamin B12 deficiency and/or diabetes mellitus.Material and Methods: An open labeled clinical study was conducted in 30 patients presenting with peripheral neuropathy and suffering from either megaloblastic anaemia (viamin B12 deficient) and/ or diabetes mellitus. Vitamin B12 levels in blood were estimated at baseline and during therapy. Vitamin K2-7 capsules (100 mcg/capsule, twice a day) was given orally for 8 weeks. Patients kept a regular record of the intensity of the symptoms during the baseline and throughout the study. Symptoms included tingling and numbness along with weakness, fatigue and cramps. The intensity of the symptoms was assessed on a Visual Analog Scale (VAS). They were followed up to 8 weeks. Blood biochemical and organ function tests were studied at the baseline, at the fourth week and at the end of the eight week. Prior to the study Ethics Committee Approval was obtained from the Ethics Committee of T. N. M. C.&B. Y. L. Nair Ch. Hospital. The trial was registered with Clinical Trial Registry of India (CTRI). (CTRI/2012/08/002930). Informed written consent was obtained from the patients before enrollment.
Results: Depending on the basal VAS score the patients were divided in a moderate group and a severe group. The moderate group had VAS score of 6-8 and the severe group had a VAS score of 8-9. By the end of eight week, the VAS score in both the groups was reduced to 1-2. The intensity specifically of tingling and numbness has reduced to a much greater extent. It was of interest to observe that ten out of 23 patients of Vitamin B12 deficiency group had residual neuropathic symptoms in-spite of adequate levels of Vitamin B12 following vitamin B12 administration. The residual neuropathic symptom score reduced following Vitamin K2-7 therapy. Vitamin K2-7 was well tolerated clinically and found to be safe as per the organ functions in all the patients. No adverse events were reported during the period of therapy.
Conclusion: This preliminary study has shown that vitamin K2-7 at a dose of 100 mcg twice a day for 8 weeks was well tolerated and safe with a therapeutic activity for the symptoms of peripheral neuropathy. However, the therapeutic efficacy needs to be evaluated further in a larger sample size, with a placebo controlled randomised double blind trial.
Keywords
Vitamin K2-7, Diabetes Mellitus, Megaloblastic Anaemia, Peripheral Neuropathy, Reverse Pharmacology.
- The Effect of Probiotic Bacillus subtilis HU58 on Immune Function in Healthy Human
Authors
1 Synergia Life Sciences Pvt. Ltd., IN
2 Synergia Life Sciences Pvt. Ltd, IN
3 Kokan Hospital, IN
4 Physicians Exclusive, LLC., IN
Source
The Indian Practitioner, Vol 70, No 9 (2017), Pagination: 15-20Abstract
Objective: Probiotic - Bacillus subtilis is known to modulate the immune function. The current study evaluates the role of Bacillus subtilis HU58 on immune function in healthy human and also for its safety and tolerability along with clinical variables.
Material and Method: An open-labeled trial was conducted in 18 apparently healthy subjects. Probiotic-Bacillus subtilis HU58 capsules were supplied by Synergia Life Sciences Pvt. Ltd. Each capsule contained 2 billion cfu of Probiotic- Bacillus subtilis HU58. These capsules were given once a day orally for 8 weeks. Blood biochemical and organ function tests including Proinflammatory cytokines (IL-6, TNF-α), NK Cell count, ESR, CBC, Lipid profile, HbA1c, Liver function test, S. Creatinine, Seropositivity (HIV, HCV, HBcAg) were studied at the baseline, at fourth week and at eight week. Prior to the study, the permission from Intersystem BioMedica Ethics Committee (ISBEC/NR-05/KM-VM/2016), Vile Parle, Mumbai was obtained. This study was registered with Clinical Trial Registry of India (CTRI) (CTRI/2016/12/007518). Informed written consent was obtained from the subjects before enrollment.
Results: At the end of 8th week it was observed that there is reduction in IL-6 by around 45 % and TNF-α by 55 % and continues to decrees. The reduction was found to be statistically significant (P<0.0001). Probiotic - Bacillus subtilis HU58 was well tolerated clinically and found to be safe as per the organ function tests in all the subjects. No serious adverse events were reported during the period of therapy.
Conclusion: This preliminary study has shown that Probiotic-Bacillus subtilis HU58 at a dose of 2 billion cfu once a day for 8 weeks was found to be well tolerated and without any side effects. However, the therapeutic efficacy needs to be evaluated further in a larger sample size and with disease specific indications.
Keywords
Probiotic - Bacillus Subtilis HU58, Immune Function, Proinflammatory Cytokines (IL-6, TNF-α).References
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- Vitamin K2-7, a Promising Solution to Peripheral Neuropathy aroused due to Multiple Myeloma Treatment
Authors
1 Empire Centre Haematology & Oncology Specialty Clinic, Mumbai, IN
2 Synergia Life Sciences Pvt. Ltd., Mumbai, IN
3 KHS MRC, Mumbai, IN
4 Gujarat Cancer Research Institute, Ahmedabad, IN
Source
The Indian Practitioner, Vol 72, No 1 (2019), Pagination: 16-20Abstract
Objective: A large number of patients with Multiple Myeloma (MM) develop Peripheral Neuropathy (PN). This is either consequent upon iatrogeny with prolonged therapy or as a part of the disease. The persistence of disabling PN, during therapy, often compels the physician to a reduction in the dose of the primary agents or their total discontinuation or replacement. Our previous study with Vitamin K2-7 has shown therapeutic activity in patients with diabetic neuropathy and/or with vitamin B12 deficiency. An anecdotal observation of considerable relief of PN in an MM patient, after chemotherapy, prompted us for this observational study. The present brief communication reports the ameliorative potential of Vitamin K2-7 in the management of iatrogenic PN in MM.
Material and Methods: This communication describes a case-series of seventeen patients with iatrogenic PN for MM. Vitamin K2-7 was given orally to patients who complained of PN till 4 chemotherapy cycles and followed up to 5th chemotherapy cycle. Symptoms included tingling, numbness along with burning sensation, fatigue and cramps. This study was approved by an independent ethics committee.
Results: Twelve out of seventeen patients reported relief. Vitamin K2-7 had allowed these twelve patients continuation of treatment for MM, without any reduction of dosage or temporary discontinuation of treatment. Three patients had discontinued the MM treatment and two had discontinued Vitamin K2-7 on their own after they did not find any marked relief.
Conclusions: This preliminary observational study, to our knowledge, suggests for the first time that Vitamin K2-7 has an ameliorative potential for relief of iatrogenic PN in MM patients. The positive directionality of the outcome necessitates a larger study with an objective assessment of PN with Nerve Conduction Velocity and with the use of validated Visual Analog Scale for subjective features of PN.
Keywords
Multiple myeloma, Vitamin K2-7, Peripheral Neuropathy, Drug-induced Neuropathy.References
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