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Clinical studies / Clinical justification:
The herb Amalaki is well supported with research papers published all over the
world in renowned medical research journals of recent times. Summary of some of
the research papers is given below to support its inclusion in NEEROGA
Capsules.
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1) J Ethnopharmacol. 2002 Jun;81(1):81-100.
Medicinal plants of India with anti-diabetic potential.
Grover JK, Yadav S, Vats V.
Department of Pharmacology, All India Institute of Medical Sciences, Ansari
Nagar, New Delhi-110049, India. jkgrover@hotmail.com
Since ancient times, plants have been an exemplary source of
medicine. Ayurveda and other Indian literature mention the use of plants in
treatment of various human ailments. India has about 45000 plant species and
among them, several thousands have been claimed to possess medicinal
properties. Research conducted in last few decades on plants mentioned in
ancient literature or used traditionally for diabetes have shown anti-diabetic
property. The present paper reviews 45 such plants and their products (active,
natural principles and crude extracts) that have been mentioned/used in the
Indian traditional system of medicine and have shown experimental or clinical
anti-diabetic activity. Indian plants which are most effective and the most
commonly studied in relation to diabetes and their complications are: Allium
cepa, Allium sativum, Aloe vera, Cajanus cajan, Coccinia indica, Caesalpinia
bonducella, Ficus bengalenesis, Gymnema sylvestre, Momordica charantia, Ocimum
sanctum, Pterocarpus marsupium, Swertia chirayita, Syzigium cumini, Tinospora
cordifolia and Trigonella foenum graecum. Among these we have evaluated M.
charantia, Eugenia jambolana, Mucuna pruriens, T. cordifolia, T. foenum
graecum, O. sanctum, P. marsupium, Murraya koeingii and Brassica juncea. All
plants have shown varying degree of hypoglycemic and anti-hyperglycemic
activity.
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2) Integr Physiol Behav Sci. 1998 Jan-Mar;33(1):61-71.
The effects of nutritional supplements on the symptoms of fibromyalgia and
chronic fatigue syndrome.
Dykman KD, Tone C, Ford C, Dykman RA.
Mannatech Inc., Coppell Texas 75019, USA.
This article reports the results of a within-subject design.
Fifty subjects with a physician diagnosis of fibromyalgia (FM) and/or chronic
fatigue syndrome (CFS) were interviewed using a structured interview from. Each
subject was interviewed initially, and again nine months later (follow-up).
Subjects had, on their own, consumed nutritional supplements including
freeze-dried aloe vera gel extract; a combination of freeze-dried aloe vera gel
extract and additional plant-derived saccharides; freeze-dried fruits and
vegetables in combination with the saccharides; and a formulation of dioscorea
complex containing the saccharides and a vitamin/mineral complex. With medical
treatments, approximately 25 percent of FM patients improve, but the beneficial
effects of medical treatment rarely persist more than a few months. All
subjects in this study had received some form of medical treatment prior to
taking the nutritional supplements, but none with enduring success. Nutritional
supplements resulted in a remarkable reduction in initial symptom severity,
with continued improvement in the period between initial assessment and the
follow-up. Further research is needed to verify these results, specifically
crossover designs in well-defined populations.
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3) Altern Med Rev. 2003 Nov;8(4):359-77.
Nutritional support for wound healing.
MacKay D, Miller AL.
Thorne Research, Inc., PO Box 25, Dover, ID 83825, USA. duffy@thorne.com
Healing of wounds, whether from accidental injury or surgical
intervention, involves the activity of an intricate network of blood cells,
tissue types, cytokines, and growth factors. This results in increased cellular
activity, which causes an intensified metabolic demand for nutrients.
Nutritional deficiencies can impede wound healing, and several nutritional
factors required for wound repair may improve healing time and wound outcome.
Vitamin A is required for epithelial and bone formation, cellular
differentiation, and immune function. Vitamin C is necessary for collagen
formation, proper immune function, and as a tissue antioxidant. Vitamin E is
the major lipid-soluble antioxidant in the skin; however, the effect of vitamin
E on surgical wounds is inconclusive. Bromelain reduces edema, bruising, pain,
and healing time following trauma and surgical procedures. Glucosamine appears
to be the rate-limiting substrate for hyaluronic acid production in the wound.
Adequate dietary protein is absolutely essential for proper wound healing, and
tissue levels of the amino acids arginine and glutamine may influence wound
repair and immune function. The botanical medicines Centella asiatica and Aloe
vera have been used for decades, both topically and internally, to enhance
wound repair, and scientific studies are now beginning to validate efficacy and
explore mechanisms of action for these botanicals. To promote wound healing in
the shortest time possible, with minimal pain, discomfort, and scarring to the
patient, it is important to explore nutritional and botanical influences on
wound outcome.
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4) Trop Med Int Health. 1996 Aug;1(4):505-9.
Management of psoriasis with Aloe vera extract in a hydrophilic cream: a
placebo-controlled, double-blind study.
Syed TA, Ahmad SA, Holt AH, Ahmad SA, Ahmad SH, Afzal M.
Department of Clinical Physiology, Malmö University Hospital, Sweden.
The purpose of this double-blind, placebo-controlled study was
to evaluate the clinical efficacy and tolerability of topical Aloe vera extract
0.5% in a hydrophilic cream to cure patients with psoriasis vulgaris. Sixty
patients (36M/24F) aged 18-50 years (mean 25.6) with slight to moderate chronic
plaque-type psoriasis and PASI (Psoriasis Area and Severity Index) scores
between 4.8 and 16.7 (mean 9.3) were enrolled and randomized to two parallel
groups. The mean duration of the disease prior to enrollment was 8.5 years
(range 1-21). Patients were provided with a precoded 100g tube, placebo or
active (with 0.5% Aloe vera extract), and they self-administered trial
medication topically (without occlusion) at home 3 times daily for 5
consecutive days per week (maximum 4 weeks active treatment). Patients were
examined on a weekly basis and those showing a progressive reduction of
lesions, desquamation followed by decreased erythema, infiltration and lowered
PASI score were considered healed. The study was scheduled for 16 weeks with 12
months of follow-up on a monthly basis. The treatment was well tolerated by all
the patients, with no adverse drug-related symptoms and no dropouts. By the end
of the study, the Aloe vera extract cream had cured 25/30 patients (83.3%)
compared to the placebo cure rate of 2/30 (6.6%) (P < 0.001) resulting in
significant clearing of the psoriatic plaques (328/396 (82.8%) vs placebo
28/366 (7.7%), P < 0.001) and a decreased PASI score to a mean of 2.2. The
findings of this study suggest that topically applied Aloe vera extract 0.5% in
a hydrophilic cream is more effective than placebo, and has not shown toxic or
any other objective side-effects. Therefore, the regimen can be considered a
safe and alternative treatment to cure patients suffering from psoriasis.
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5) Nat Immun. 1998;16(1):27-33.
Biotherapy with the pineal immunomodulating hormone melatonin versus melatonin
plus aloe vera in untreatable advanced solid neoplasms.
Lissoni P, Giani L, Zerbini S, Trabattoni P, Rovelli F.
Division of Radiation Oncology, San Gerardo Hospital, Monza, Milan, Italy.
The possibility of natural cancer therapy has been recently
suggested by advances in the knowledge of tumor immunobiology. Either cytokines
such as IL-2, or neurohormones, such as the pineal indole melatonin (MLT), may
activate anticancer immunity. In addition, immunomodulating substances have
also been isolated from plants, particularly from Aloe vera. Preliminary
clinical studies had already shown that MLT may induce some benefits in
untreatable metastatic solid tumor patients, whereas, for the time being, no
clinical trial has been performed with aloe products. We have carried out a
clinical study to evaluate whether the concomitant administration of aloe may
enhance the therapeutic results of MLT in patients with advanced solid tumors
for whom no effective standard anticancer therapies are available. The study
included 50 patients suffering from lung cancer, gastrointestinal tract tumors,
breast cancer or brain glioblastoma, who were treated with MLT alone (20 mg/day
orally in the dark period) or MLT plus A. vera tincture (1 ml twice/day). A
partial response (PR) was achieved in 2/24 patients treated with MLT plus aloe
and in none of the patients treated with MLT alone. Stable disease (SD) was
achieved in 12/24 and in 7/26 patients treated with MLT plus aloe or MLT alone,
respectively. Therefore, the percentage of nonprogressing patients (PR + SD)
was significantly higher in the group treated with MLT plus aloe than in the
MLT gorup (14/24 vs. 7/26, p < 0.05). The percent 1-year survival was
significantly higher in patients treated with MLT plus aloe (9/24 vs. 4/26, p <
0.05). Both treatments were well tolerated. This preliminary study would
suggest that natural cancer therapy with MLT plus A. vera extracts may produce
some therapeutic benefits, at least in terms of stabilization of disease and
survival, in patients with advanced solid tumors, for whom no other standard
effective therapy is available.
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