Description

Lako Herbal  is indicated for the treatment of Piles and Constipation.

NAME OF PRODUCT: Lako Herbal Mixture

DOSAGE FORM: Decoction ACTIVE

INGREDIENTS: Paullinia pinnata, khaya senegalensis, Piper guineense

EXCIPIENTS: sodium Benzoate

INDICATION: This product is indicated for the treatment of Piles and Constipation.

DOSAGE AND ADMINISTRATION Route of Administration: Lako Herbal Mixture must be taken orally Dosage Adults (18 years and above) The usual dose is; three (3) tablespoonful (45ml) three times (3X) daily for Seven (7) days Children (12 years to 17 years) Two (2) tablespoonfuls (30ml) three times (3X) daily for Seven (7) days If you forget to take a dose of Lako Herbal Mixture, take the prescribed dose as soon as you remember and continue the rest of the dosage exactly as indicated above. Do not take double dose to make up for forgotten dose.

SIDE EFFECTS Lako Herbal Mixture is well tolerated. It has no Active ingredient known to cause drowsiness or dizziness. It therefore has no effect on driving or machinery operation.

WARNING /CAUTION Do not use Lako Herbal Mixture if:  you are allergic to leaves, stem barks and roots of any of the Active Ingredients. -your condition has not been diagnosed as Piles or Constipation Please inform your prescriber you are taking Lako Herbal Mixture, when other drugs are going to be prescribed for you, including allopathic over-the-counter-medicines.

CONTRAINDICATIONS Lako Herbal Mixture is not recommended for pregnant women, lactating mothers and individuals below twelve (12) years.
INTERACTION WITH FOOD AND DRUGS Lako Herbal Mixture is well tolerated with food and should be taken preferably after meals. Please consult your doctor or Health Provider if you are taking any other medicines

OVER-DOSAGE AND MANAGEMENT If you take overdose of Lako Herbal Mixture, drink plenty of water and consult your Health Care Provider immediately. Do not induce vomiting.
The Observable Adverse Effect Level (OAEL) of Lako Herbal Mixture is greater than three times (3X) the stated daily dose.
STORAGE AND HANDLING; Store Lako Herbal Mixture in a cool dry place away from direct sunlight

CLINICAL PHARMACOLOGY Efficacy, Acute and Sub-Chronic Toxicity Test Experimental Procedure A total of 36 Sprague-Dawley rats were grouped into six (1 – 6) comprising of six animals each. Animals in Group 1 (non-constipated control) were administered with 1 ml of normal saline while those in groups 2, 3, 4 5 and 6 were all induced with constipation and administered with 1 ml each of normal saline, 5 mg/kg Senna, 50, 100 and 200 mg/kg/day of Lako Herbal mixture respectively. The administration was done once daily for 7 days using metal oropharyngeal cannula. The water intake, feed intake and body weight gain of all the rats were recorded during experimental period of 7 days. Furthermore, fecal pellets from each rat were collected daily and the total number, weight and water content determined. The water content was computed as the difference between the wet and dry weights of the pellet. Induction of constipation Constipation was induced in the animals by oral administration of 1 ml of loperamide (3 mg/kg body weight in 0.9% sodium chloride for 3 days). The passage of reduced, hard and dry fecal pellets by the rats was used as a measure of constipation. Prostaglandin – Induced Paw Edema Prostaglandin E2, 0.2 ml (1nM) was administered into the sub-planter region of the right hind paw of rats. The paw volume up to the ankle joints were measured plethysmographically before and after 30 min of the prostaglandin E2 stimulation. Each group was treated with either an extract from Lako Herbal Mixture (50, 100 and 200 mg/kg, per os) or Diclofenac sodium (0.93 mg/kg, i.p). the control group received distilled water (1 ml/kg, per os). Paw edema was measured 0.5, 1, 1.5, 2 and 2.5 h post- treatment and the percentage changes in paw volumes calculated and recorded.

Lako herbal mixture

RESULTS

Loperamide-induced Constipation Compared with the unconstipated normal saline treated animals, the loperamide significantly (p<0.05) reduced the feed and water intake respectively, which was significantly restored by both Senna and Lako herbal mixture treatment in addition, the fecal parameters (number, water content and weight) reduced significantly in the loperamide treated animals. This was again restored significantly by drug treatment.

Anti-inflammatory Effect Having treated the rats with the reference drugs and Lako herbal mixture, it was observed then on that the 50, 100 and 200 mg/kg treated groups had significant reduction (P s0.01-0.0010) in paw edema in the prostaglandin-induced inflammation; All reference drugs caused very significant reductions (P $0.001). These observations signify that Lako Herbal Mixture have anti-inflammatory properties comparable to the reference drugs

Toxicity Test

NUAEL, NO– bser ab REMARKS Level Lako Herbal Mixture relieves constipation and has anti-inflammatory effect.

The OAEL is greater than three times the stated daily dosage indicated. The recommended dose is thus within acceptable margin of safety.

PHYTOCHEMICAL PROPERTIES:Major chemical constituents in Lako Herbal Mixture include; Reducing Sugars, Saponins, Tannins, Alkaloids and flavonoids.

PHYSICOCHEMICAL DATA: PH (aq. Extract) –6.24 AVERAGE WT PER ML—1.0416 gm/ml DRY WT PER ML—– 0.0703gm/ml

DETAILS OF MANUFACTURER: PRODUCED IN GHANA BY; SOLAK BIOCHEMIST P. O. Box SE 788, Suame – Kumasi Ashanti Region, Ghana Location: Pit. 37, Blk. B, Ekyem – Fumesua Kumasi, Ashanti Region, Ghana GPS Address (AE – 0533-2502) Tel/Mob: 0245616028 / 0261736263 Country of Origin: Ghana Language: English