Hilo Capsules

Commiphora molmol (Pura) Oleoresin, Gardenia gummifera (Naadihingu) Gum resin, Tagates erecta (Genda) Flowers, Mesua ferrea (Nagakesar)

Each Capsules contains extract

Commiphora molmol (Pura) Oleoresin 250 mg

Gardenia gummifera (Naadihingu) Gum resin 83 mg

Tagates erecta (Genda) Flowers 83.5 mg

Mesua ferrea (Nagakesar) Stem 83.5 mg

(Standardized to contain not less than 7% catechins and epicatechins)

Capsule, 500mg

4.1 Therapeutic Indication

For the treatment of hemorrhoids (piles) and anal fissure.

4.2 Posology and method of administration

2 capsules twice a day for 15 days or as directed by the Physician

Method of administration: Oral

4.3 Contraindications

• Hypersensitivity to the active substances or to any of the excipients
• Catechins decrease platelet aggregation and hence when patient is on drugs like aspirin which also decrease platelet aggregation caution should be administered

4.4 Special warnings and precautions for use

• Recommended not to be taken by pregnant women, lactating mothers and children below 8 years unless taken under medical supervision
• Do not exceed the recommended dosage
• Strictly adhere to product directions to achieve maximum benefits of Hilo
• Avoid spicy food and salt intake
• Please keep this product out of reach of children

4.5 Drugs interactions

• Catechins decrease platelet aggregation and hence when patient is on drugs like aspirin which also decrease platelet aggregation, caution should be administered.
• Green tea catechin supplementation should be stopped before any surgical procedure.

4.6 Use in special populations

No known data on special population.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Some cases of routine gastric disorders and neurovegetative disorders (feeling of discomfort) have been reported, not requiring discontinuation of treatment.

4.9 Overdose

No cases of overdose have been reported.

5.1 Mechanism of Action

Hemorrhoids are defined as the symptomatic enlargement and distal displacement of the normal anal cushions.

The most common symptom of hemorrhoids is rectal bleeding associated with bowel movement. The abnormal dilatation and distortion of the vascular channel, together with destructive changes in the supporting connective tissue within the anal cushion, is a paramount finding of hemorrhoids. The dysregulation of the vascular tone and vascular hyperplasia might play an important role in hemorrhoidal development.

Hilo is a venotonic drug and a vascular-protecting agent. The efficacy of Hilo is accounted for by its specific action on the principal elements of venous disease.

Venotonic: Hilo reinforces venous tone, decreases venous capacitance, venous distensibility and venous emptying time.

Vascular-protecting agent: Hilo protects the microcirculation by fighting the microcirculation-damaging process; it combats venous inflammation by decreasing leukocyte activation, and as a consequence, by inhibiting the release of inflammatory mediators (Cytokines, IL 1-β & TNFα), principally free radicals (5-LOX, ROS & RNS) and prostaglandins. Thus, Hilo normalizes capillary permeability and strengthens capillary resistance.

Hilo acts on the lymphatic system: It improves lymphatic drainage by increasing lymph flow and lymph oncotic pressure. This action on the lymphatic system associated with a venotonic and vasculoprotective effect, explains the activity of Hilo on edema.

By virtue of its venotonic, vascular-protecting and anti-inflammatory action, Hilo improves hemorrhoidal symptoms and signs e.g., anal discomfort, pain, redness, anal discharge, tenesmus, pruritus, erythema and bleeding. It also significantly reduces the frequency, severity and duration of acute hemorrhoidal attacks and bleeding by chronic treatment in all grades of haemorrhoids.

5.2 Pharmacodynamic properties

Commiphora molmol (Pura)

Several studies revealed that the resinous exudates of different Commiphora tree species produced analgesic and anti-inflammatory, antiulcer, antioxidant, anti-hyperlipidemic, hypoglycemic, and cardioprotective effects. The resinous exudates of different Commiphora tree species have been used for arthritis, hyperlipidemia, and pain, inflammatory conditions, healing of wounds, obesity, schistosomiasis, and gastrointestinal diseases.

In Ayurvedic medicine, myrrh has long been used to treat problems associated with the mouth, such as gingivitis, mouth ulcers, and pharyngitis (sore throat). In modern Chinese medicine, myrrh is used for improving blood circulation; treating traumatic injuries; incised wounds; bone, tendon, and ligament pain; amenorrhea; and hemorrhoids or other painful swellings.

Externally, myrrh has been used for hemorrhoids and wounds. Myrrh has astringent properties that help bind skin to create a barrier against infection.

Gardenia gummifera (Naadihingu)

Nadihingu is pungent in taste, pungent in the post digestive effect and has hot potency. It alleviates kapha and vata doshas. It possesses light, dry and sharp attributes. It facilitates the vata through intestines and helps to remove the obstruction and constipation. It is useful in flatulence and constipation.

The dried resin of the plant Gardenia gummifera is dissolved in water and given to patients suffering from intestinal worms, distention of abdomen, constipation and piles.

Tagates erecta (Genda Flowers)

In traditional and homeopathic medicine flower leaves has been used for skin complaints, wounds and burns, conjunctivitis and poor eyesight, menstrual irregularities, varicose veins, hemorrhoids, duodenal ulcers, etc. The flowers are especially employed as a remedy for bleeding piles and said to purify blood. Lutein is an oxycarotenoid or xanthophyll. It is one of the major constituents and the main pigment of Tagetes erecta.

Mesua ferrea (Nagakesar)

Stem It possesses various pharmacological constituents like 4-phenyl cumarin analogues, oleic acid, stearic acid, palmitic acid, B-sitosterol, two new bioflavonoids and lupeol type of triterpenoid.

Ayurvedic Properties: Powder of Nagakesara (stamens of flowers of Mesua ferrea Linn.), butter (navanita) and sugar (sarkara) are mixed and orally given to patients of bleeding piles or haemorrhoids (raktarsa) as well as dysentery with mucus.

Piles (Arsh) are vascular structures in the anal canal which gets swollen and inflamed and the patient feels difficult to defecate with continuous throbbing (pin pricking ) pain along with bleeding stools, Nagkesar reduces the Swelling and Shrinks the Piles, Eradicating the Pain and Stops the Bleeding.

Catechins & Epicatechins

[Oligomeric Proanthocyanidins]

Hilo is a processed and standardized herbal preparation containing catechins & epicatechins, which are the monomers of naturally occurring proanthocyanidins.

Mechanism of action of Flavonoids i.e.Oligomeric proanthocyanidins (OPC)

• OPCs crosslink the collagen fibers in the vessel basement membranes which make them stronger and less permeable
• The proanthocyanidins or monomeric catechins increase plasma antioxidant activity and also show beneficial effects on capillary fragility & permeability
• Inhibition of enzymes hyaluronidase, elastase and collagenase which degrade the connective tissue leading to increased capillary permeability
• OPCs prevent the release and synthesis of compounds associated with inflammation and allergies such as histamine, serine proteases, prostaglandins and leukotrienes.
• Carry vitamin C to the basement membranes which leads to increased production of collagen making vessels (veins) strong

It has been observed that oligomeric proanthocyanidins are about 20 times more effective at trapping oxygen radicals than some of the commonly used bioflavonoids. By exhibiting strong antioxidant and vasculoprotective activity, Hilo brings relief to patients with hemorrhoids and/or anal fissures.

5.3 Pharmacokinetic properties

No known pharmacokinetics data.

6.1 Animal Toxicology or Pharmacology

Acute oral toxicity study was conducted in Sprague Dawley Rats (Including both sexes 10 male & 10 non-pregnant female, 6 to 8 weeks age, 5 males & 5 females each randomly assigned in drug treated group and in control group, randomly assigned). No sign of intoxication was observed in animals treated at the dose level of 2000mg/kg of the test substance. All animals survived through the study period of 14 days. The rats were deprived of feed for 16 hours before and 3 hours after the administration of the test substance. The test substance, suspended in 0.1% aqueous carboxy methyl cellulose was administered once by oral route to rats.

It was concluded that acute lethal oral dose in Sprague Dawley Rats was found to be greater than 2000 mg/kg body weight.

Commiphora molmol is small perennial tropical trees that grown in arid and semiarid regions in East Africa, Saudi Arabia, and India. Myrrh is a resinous exudate (oleo-gum resin) obtained from the stem of C. molmol trees. Myrrh has been approved by USFDA as a safe natural flavoring agent in foods and beverages and as fragrance in cosmetics. For many years, myrrh (oleo-gum resin) has been used for healing wound injuries.

Nadi hingu- Gardenia gummifera is an herb mentioned in the ayurvedic pharmacopoeia for the treatment of fever, digestive disorders, dental problems during eruption, wounds, skin diseases and pain in abdomen due to intestinal worm or constipation. The plant grows all over India, in deciduous forests, especially in Maharashtra, Gujarat, Bihar and South India.

Tagetes erecta, popularly known as marigold, is grown as an ornamental plant. Flowers of this plant are used loose or in garlands for social and religious purposes in Eastern countries (India).

Nagakesara (Mesua ferrea Linn.) has its special place in Ayurveda as the drug is useful for multi system disorders and this drug happens to be most consumed drug by domestic industries in volumes (million tons) after Amalaki and Hareetaki.

Catechins & epicatechins belong to the class of flavonoids. When the number of connected catechins is 10 or less they are called oligomers and thus the term used is "Oligomeric Proanthocyanidins." (OPC).

8.1 Incompatibilities

None stated

8.2 Shelf-life

Refer on pack

8.3 Packaging information

30 capsule/bottle

8.4 Storage and handing instructions

Store in cool and dry place away from direct sunlight. Do not refrigerate.

Keep out of reach of children.

• Do not exceed the recommended dosage
• Read the label carefully before use
• Keep at least half an hour gap between food/drink/ any other medicines and allopathic medicine
• Report any untoward or undesirable effect which has not been mentioned in this package insert to your doctor.

13-06-2024