|Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka.
Comparative study of polyherbal formulation and its ingredients for acute Anti-hyperglycemic activity
A Protocol submitted to Rajiv Gandhi University of Health Sciences
In partial fulfilment of the requirement for the award of
Master of Pharmacy
National College of Pharmacy
A. BRIEF RESUME OF INTENDED WORK
A.1 Need for the study
Ailments are the inseparable companions of the life. The efforts to heal ailments and the desire to attain vitality and longevity prompted the early man to explore the natural surroundings. In his quest, the herbs became the early medicines of the man. Remarkably, still 80% of the world population relies on traditional medicines. World Health Organisation encourages the traditional medicines as they are inexpensive, easily and abundantly available, and also relatively free from adverse effects. There are many medicinal herbs and spices, which find place in day-to-day uses, many of these, are used as herbal remedies. Some minor ailments like common cold, cough etc may be cured by herbal remedies with use of spices having medicinal properties.
Many cultures around the globe have evolved medicinal systems. The examples being ayurvedic systems in India and traditional chinese medicine of China. These systems of medicine rely solely on natural resources for the drugs. They have established their own diagnosing system and prescribed various formulations for the treatment.
There is a renewed interest in the complementary system of medicine. This is because of side and adverse effects of allopathic medicine, especially in the treatment of chronic diseases. In the conditions like hypertension, diabetes and asthma patients needs to take medicines lifelong, which is usually either a single chemical entity or a few synthetic organic molecules. Certainly, intake of these chemical entities as drugs for an extended period of time bound to cause complications in overall health of the patient. Hence, there is a growing demand for alternative systems of medicine which uses medicines from natural sources.
Polyherbal formulations contain ingredients from more than one plant. They are likely to contain mixture various types of organic molecules. In these preparations, the quantity of any one molecule is very less. Hence, even on prolonged usage they are less likely to cause side effect and hence considered safe.
Most of the times these formulations are not based on any scientific data but merely on their traditional claim. In such a situation, use of ingredients that are not contributing to the pharmacological activity to cure the disease is not justified. It unnecessarily puts the burden of metabolism on liver and may act antagonistically with other ingredients. It also unnecessarily burdens the patient economically and put pressure on environment.
‘Diabit Compound’ is a proprietary poly herbal formulation used in hyperglycaemic conditions. It is in local market for more than 40 years and very popular among herbal anti hyperglycaemic preparations. It contains ingredients from five different plant sources in various proportions. Ingredients used in this formulation are Cassia auriculata, Tinospora cordifolia, Syzygium cuminii, Ficus racemosa, and Curcuma longa.
This formulation is not based on any scientific studies. Hence in this work we are intended to screen the contribution of ingredients of Diabit compound in reducing elevated glucose level in experimental animals. The present study involves screening of Diabit compound and various combinations of the ingredients used in the formulation to ascertain the level of contribution of these ingredients in reducing elevated blood glucose level.
A.2 Review of literature:
Phytochemical screening of Cassia auriculata plant extract found to contain presence of terpenoids, tannin, flavonoids, saponin, cardiac glycosides and steroids 1.
Aqueous extract of Cassia auriculata flower reported to reduce blood glucose level in experimental animals2.
Tinospora cordifolia found to contain tinosporin, isocolumbin, palmatine, tinocordiside, Cordioside, ß-sitostrol. It is reported to exhibit antidiabetic, antihyperlipidemic, and antioxidant properties3.
Prince et al reported anti-diabetic and anti-hyperlipidemic effect of alcoholic extract of Syzygium cuminii. Plant found to contain gallic acid, oxalic acid, citric acid, glycolic acids, ellagic acid, betulinic acid, friedelin, friedelan-3-α-ol β-sitosterol, anthocyanins, and petunidin-3-gentiobioside4.
Fruits of Ficus racemosa found to contain gluanol, hentriacontane, β-sitosterol, gluanol acetate, glucose, tiglic acid, esters of taraxasterol, lupeol acetate, friedein higher hydrocarbons and other phytosterol5. The ethanolic extract of stembark of Ficus racemosa reduced blood glucose level in alloxan induced diabetic rats6.
Curcuma longa reported to contain curcumin, desmithoxy curcumin, bisdesmithoxy Curcumin, dihydrocurcumin, α & ß turmerome, eugenon, campestrol, stigmastrol. The ethanolic extract of Curcuma longa has exhibited anti-diabetic, anti-hyperlipidemic, antioxidant properties7.
Snehal Patel et al investigated the anti-hyperglycemic, anti-hyperlipidemic and antioxidant activities of Dihar, a Polyherbal formulation containing drugs from eight different herbs viz., Syzygium cuminii, Momordica charantia, Emblica officinalis, Gymnema sylvestre, Enicostemma littorale, Azadirachta indica, Tinospora cordifolia and Curcuma longa in streptozotocin (STZ, 45mg/kg iv single dose) induced type 1 diabetic rats. Treatment with Dihar (100 mg/kg) for 6 weeks produced decrease in STZ induced serum glucose and lipids levels and increased insulin levels as compared to control. The results suggest Dihar to be beneficial for the treatment of type 1 diabetes8.
Rahul Mandlik et al reported that the herbal formulation, DRF/AY/5001, elicits hypoglycaemic/anti-diabetic effects in both normal and experimentally induced hyperglycaemic (epinephrine and alloxan) rats9.
B.MATERIALS AND METHODS:
B.1.Source of data:
The required data will be obtained from:
1. Electronic data (Internet).
2. Published research papers.
3. Review & research articles from journals.
4. Kuvempu University, library. Shankaragatta.
5. Library of National College of pharmacy, Shivmogga.
B.2 Methods of collection of data
a. All plant sample required will be collected from local areas of Shivmogga, Karnataka.
b. Authentication: The plant will be authenticated by a botanist.
c. Extraction of plant material. The powdered plant material and Diabit compound will be extracted with alcohol.
d. Pharmacological activity: The evaluation of anti-hyperglycemic activity will be carried out by using animal model. The animals will be induced hyperglycaemia using alloxan monohydrate. The alcoholic extract of plant material in different combination and alcoholic extract of Diabit compound will be given to both normal and hyperglycaemic animals. The effect of extracts on blood glucose level will be monitored by using glucometer.
B.3. Does the study requires any investigation or intervention to be conducted o patient or other human/ animals? If so, please describe briefly.
The above study requires investigation on albino rats to evaluate anti-hyperglycaemic activity. This study planned in accordance with the procedure reported in the literature.
B. 4. Has ethical clearance been obtained from your institution?
Ethical clearance is provided by the institution.
Clearance number: NCP/IAEC/CL/28/ 05/ 2011-12.
Maneemegalai S and Naveen. “Evaluation of Antibacterial Activity of Flower Extracts of Cassia auriculata”, Ethnobotanical Leaflets; 2010, 14:8-20.
Pari L and Latha M. “Effect of Cassia auriculata Flowers on Blood Sugar Levels, Serum and Tissue Lipids in Streptozotocin diabetic rats”, Singapore Medical Journal; 2002, 43(12): 617-621.
Gupta S. “Anti-diabetic effects of Tinospora cordifolia”, Indian Journal of Medical Research; 1967, 55: 733.
Prince PS, Kamalakkannan N and Menon VP. “Anti-diabetic and antihyperlipidemic effect of alcoholic extract of Syzygium cuminii seeds in alloxan induced diabetic albino rats”, Journal of Ethnopharmacology; 2004, 91: 209.
Padmaa Paarakh M. “Ficus racemosa Linn. - An overview”, Natural Product Radiance; 2009, 8(1): 84-90.
Shrotri DS and Ranita A. “The relationship of post-absorptive state to the hypoglycaemic action studies on Ficus bengalensis and Ficus racemosa”, Indian Journal of Medical Research; 1960,48: 162-168.
Halim EM and Ali H. “Hypoglycemic, hypolipidemic and antioxidant properties of combination of curcumin from Curcuma longa, Linn, and partially purified product from Abroma augusta, Linn. in streptozotocin induced diabetes”, Indian Journal of Clinical Bio Chemistry; 2002, 17: 33.
Snehal Patel S, Rajendra Shah S and Ramesh Goyal K. “Anti-hyperglycemic, antihyperlipidemic and antioxidant effects of ‘ Dihar’, a polyherbal ayurvedic formulation in streptozotocin induced diabetic rats”, Indian Journal Experimental Biology; 2009, 47: 564-570.
Rahul Mandlik V, Sandya Desai K and Suresh Naik R. “Anti-diabetic activity of poly herbal formulation (DRF/AY/5001)”, Indian Journal Experimental Biology; 2008, 46: 599-606.