Clinical Trial Details
— Status: Available
Administrative data
| NCT number |
NCT02065674 |
| Other study ID # |
ABROAGUS01 |
| Secondary ID |
|
| Status |
Available |
| Phase |
Phase 2
|
| First received |
February 13, 2014 |
| Last updated |
June 5, 2015 |
| Start date |
February 2014 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
June 2015 |
| Source |
Fr Muller Homoeopathic Medical College |
| Contact |
dr rita chakraborty, MD |
| Phone |
+919448309048 |
| Email |
ritapranab[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
India: Institutional Review BoardIndia: Indian Council of Medical Research |
| Study type |
Expanded Access
|
Clinical Trial Summary
Objective: To ascertain whether homoeopathic medicine ABROMA AUGUSTA has a clinical role in
changing the Glycated Hb Level in Diabetes mellitus Type II.
Abstract:
Background: Type 2 diabetes mellitus (T2DM) is one of the most important epidemic diseases
in the world in this century, and accounts for 90% of cases of diabetes globally. Studies
have suggested that Abroma Augusta plays a role in acute controlling blood glucose level.
The aim of this study was to evaluate the efficacy of "Abroma Augusta Ѳ" in chronic control
through GlycatedHb (HbA1c %) in Diabetes Mellitus Type 2 (NIDDM) as a pretest post-test
study.
Description:
Introduction:
Diabetes mellitus type 2 (noninsulin-dependent diabetes mellitus (NIDDM) or adult-onset
diabetes) is a metabolic disorder that is characterized by hyperglycemia (high blood sugar)
in the context of insulin resistance and relative lack of insulin. According to recent
survey reports about 5% of the total world population is suffering from Diabetes Mellitus.
The incidence rate is also reasonably high in India. Currently about 20% of Indian
Population is at High risk to develop Diabetes Mellitus in future i.e. they are having
abnormal glucose Tolerance test. Studies have revealed that diabetic women suffer more than
men. Diabetes is the single most important metabolic disease which can affect nearly every
organ system in the body. According to the World Health Organization estimates, India had 32
million diabetic subjects in the year 2000 and this number would increase to 80 million by
the year 2030. The International Diabetes Federation (IDF) also reported that the total
number of diabetic subjects in India is 41 million in 2006 and that this would rise to 70
million by the year 2025. A male who is diabetic has double the chances of heart failure. In
case of women it grows to almost 5 times and it is 8 times more if the patient is a young
female.
The prevalence of diabetes is rapidly rising all over the globe at an alarming rate1 . Over
the past 30 yr, the status of diabetes has changed from being considered as a mild disorder
of the elderly to one of the major causes of morbidity and mortality affecting the youth and
middle aged people. It is important to note that the rise in prevalence is seen in all six
inhabited continents of the globe2 . Although there is an increase in the prevalence of type
1 diabetes also, the major driver of the epidemic is the more common form of diabetes,
namely type 2 diabetes, which accounts for more than 90 per cent of all diabetes cases.
Nowhere is the diabetes epidemic more pronounced than in India as the World Health
Organization (WHO) reports show that 32 million people had diabetes in the year 2000. The
International Diabetes Federation (IDF) estimates the total number of diabetic subjects to
be around 40.9 million in India and this is further set to rise to 69.9 million by the year
2025.
Long-term complications of diabetes develop gradually. The longer you have diabetes — and
the less controlled your blood sugar — the higher the risk of complications. Eventually,
diabetes complications may be disabling or even life-threatening. Possible complications
include:
- Cardiovascular disease.Diabetes dramatically increases the risk of various
cardiovascular problems, including coronary artery disease with chest pain (angina),
heart attack, stroke and narrowing of arteries (atherosclerosis).
- Nerve damage (neuropathy). Excess sugar can injure the walls of the tiny blood vessels
(capillaries) that nourish your nerves, especially in your legs. This can cause
tingling, numbness, burning or pain that usually begins at the tips of the toes or
fingers and gradually spreads upward. Left untreated, you could lose all sense of
feeling in the affected limbs. Damage to the nerves related to digestion can cause
problems with nausea, vomiting, diarrhea or constipation. For men, it may lead to
erectile dysfunction.
- Kidney damage (nephropathy). The kidneys contain millions of tiny blood vessel clusters
(glomeruli) that filter waste from your blood. Diabetes can damage this delicate
filtering system. Severe damage can lead to kidney failure or irreversible end-stage
kidney disease, which may require dialysis or a kidney transplant.
- Eye damage (retinopathy). Diabetes can damage the blood vessels of the retina (diabetic
retinopathy), potentially leading to blindness. Diabetes also increases the risk of
other serious vision conditions, such as cataracts and glaucoma.
- Foot damage. Nerve damage in the feet or poor blood flow to the feet increases the risk
of various foot complications. Left untreated, cuts and blisters can develop serious
infections, which often heal poorly. These infections may ultimately require toe, foot
or leg amputation.
- Skin conditions. Diabetes may leave you more susceptible to skin problems, including
bacterial and fungal infections.
- Hearing impairment. Hearing problems are more common in people with diabetes.
- Alzheimer's disease. Type 2 diabetes may increase the risk of Alzheimer's disease. The
poorer your blood sugar control, the greater the risk appears to be. Although there are
theories as to how these disorders might be connected, none has yet been proved.
So Diabetes is associated with long term complications that affect almost every major part
of the body. Type 2 diabetes is initially managed by increasing exercise and dietary
changes. If blood sugar levels are not adequately lowered by these measures, medications or
intervention is needed. In those on medication, there is absolute requirement of routinely
check up of blood sugar levels.
There is good number of Homoeopathic medicine to control blood sugar level. They are
Cephalandra Indica, Syzegium, Gymnema Sylvestree, Abroma Augusta, Rhus Aromatica rtc. It is
noticed that the blood sugar (HbA1c) is not controlled by other system of medicine; the
patients come for Homoeopathic treatment and after homoeopathic treatment there is a
remarkable improvement in FBS, PPBS as well as HbA1c along with the general improvement of
health like tiredness, lethargy, numbness, polyurea, polydypsia and polyphagia etc. But
there is no scientific validation for that. Among those Abroma Augusta is selected for this
study and this study is conducted for achieving the scientific validation, the homoeopathic
hypoglycemic "Abroma Augusta".
ABROMA AUGUSTA Family: Sterculiaceae Bengali/vernacular name: Ulatkambal. Tribal name:
Polumaoeba (Chakma); Daiya (Garo). English name: Devil's Cotton. Usually it has been used
widely as an emmenagogue but its glycemic use is rare. Abroma Augusta commonly known as Olat
Kambal. The plant of Abroma Augusta grows wild throughout the hotter part of India. In
ancient times, it was used therapeutically as an emmenagogue in menstrual disorders. Late
Dr. D.N.Roy of Calcutta proved this drug. A tincture of the drug is prepared from its leaves
according to class III of American Homeopathic Pharmacopoea. It is used in diabetes
insipidus with very gratifying results. Clinically it is indicated in Diabetes, albuminuria,
enuresis, debility, vertigo, sleeplessness, carbuncle, amenorrhoea and dysmenorrhoea.
Description of the plant: ABROMA AUGUSTA L. is a large shrub. Leaves large, 10-15 by 10-12.5
cm, repand - denticulate, upper smaller, narrower, entire. Flower is solitary, auxiliary,
pendulous, peduncle up to 4 cm long; sepals 2.5 cm, lanceolate; petals scarcely exceeding
the sepals, dark red.
Chemical constituents:
Leaves contain taraxerol, its acetate and β-sitosterol. Stem bark contains friedelin and
β-sitosterol. Root and root bark contain gum, fixed oil, resin, alkaloids, abromine, choline
and betaine, β-sitosterol, stigmasterol, digitonide, magenesium salts of hydroxyl acids and
polysaccharide. Seeds contain 20.2% fixed oil with 71.5% linoleic acid. Augustic acid an
oleanane derivative and a stigmasterol glycoside have been isolated from the roots.
Heartwood contains β-sitosterol, glycol and octacosane-1, 28-diol (Ghani, 2003; Rastogi &
Mehrotra, 1993; Asolkar et al., 1992). Among them Taraxerol is the most important component
which has hypoglycemic as well as anti-inflammatory action. It also contains flavinoid &
phenolic component and they are phyto- antioxidant.
Homoeopathic uses: Fragmentary proving was conducted by Dr. D.N. Ray of Calcutta in 1919 and
Dr. Jugal Kishore of New Delhi in 1972. It has been subsequently proved by CCRH and has
shown its affinity for female reproductive organs producing symptoms of dysmenorrhoea and
leucorrhoea, which have been confirmed during verification trials too.
Diabetes mellitus - Urine profuse < at night and of high specific gravity. Excessive thirst
with dryness of mouth. Patient suffers from insomnia and prostration, and patient is averse
to do any physical and intellectual labour. Mentally patient is of irritable nature,
forgetful and morose.
Dysmenorrhoea - Colicky pains in lower abdomen. Menses are irregular, lasting for short or
long time. Blood is dark and clotted.
There is lots of study on Aboma Augusta in modern system of Medicie as well as the Ayurveda
on Rats and it was proved that this drug has not only the hypoglycemic effect (Taraxerol)
but also has effect on antioxidant and lipid control. So this study was conducted to
investigate the therapeutic efficacy on Human being.
