Abstract:
A natural supplement in the form of an orally ingested tablet for treatment of hemorrhoids. Bromelain and Psyllium (e.g., Psyllium husk powder) are the primary active ingredients in the natural supplement tablet. Optionally, Witch Hazel, in the form of Witch Hazel leaf, for example, may be added to the composition. Secondary ingredients include Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid and Silicon Dioxide. Based on case studies the natural supplement outperforms over-the-counter and prescribed hemorrhoid medications.

Description:
RELATED APPLICATIONS 
       [0001]    This application is related to co-pending U.S. application Ser. No. 12/______ and U.S. application Ser. No. 12/______, both of which are filed herewith and incorporated herein in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The embodiments of the present invention relate to an oral composition for the treatment of hemorrhoids. 
       BACKGROUND 
       [0003]    Hemorrhoids are swollen veins in the anal canal. Millions of people suffer from hemorrhoids and a majority of adults will suffer from hemorrhoids at one point in their life. Treatments for hemorrhoids range from surgery to topical ointments. Surgery includes rubber band ligation, cryosurgery and surgical hemorrhoidectomy. Non-surgical procedures include the application of heat, use of lasers or electric current to create scar tissue, or sclerotheraphy. Medicinal treatments include ointments and creams such as Preparation H® which may be applied directly or via medicated wipes and the like. Despite the various treatments, hemorrhoids continue to flourish. 
         [0004]    Thus, there exists a need for natural treatment to more reliably and efficiently treating hemorrhoids. 
       SUMMARY 
       [0005]    Accordingly, one embodiment of the present invention is a supplement tablet or pill including at least one or more anti-inflammatory agents and a laxative agent. In one embodiment, the supplement tablet includes one or both of Bromelain and  Hamamelis Virginiana  (commonly known as Witch Hazel) as the anti-inflammatory agent and Psylluim as a laxative. Other ingredients are compounded with the Bromelain and/or Witch Hazel and Psylluim to form a tablet or pill as the delivery vehicle. 
         [0006]    In one embodiment, for active symptoms, the supplement tablet is taken three times per day for 10 days. For lesser symptoms, the natural supplement tablet may be taken once per day. As evidenced by the case studies described below, the use of the natural supplement tablet reduces dramatically the swelling, pain, bleeding and other symptoms associated with hemorrhoids. 
         [0007]    Other variations, embodiments and features of the present invention will become evident from the following detailed description, drawings and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  illustrates an ingredient list for a natural supplement tablet according to one embodiment of the present invention; 
           [0009]      FIG. 2  illustrates a flow chart detailing one treatment protocol utilizing the natural supplement tablet according to the embodiments of the present invention; and 
           [0010]      FIG. 3  illustrates a kit container designed to hold a container of the soaking agent along with the tablets and gel/ointment as described in the referenced co-pending applications. 
       
    
    
     DETAILED DESCRIPTION 
       [0011]    It will be appreciated by those of ordinary skill in the art that the invention can be embodied in other specific forms without departing from the spirit or essential character thereof. The presently disclosed embodiments are therefore considered in all respects to be illustrative and not restrictive. 
         [0012]    A natural treatment for hemorrhoids has benefits for both the individual with the ailment and society as a whole. The benefit to society is a decreased need for surgery, prescription drugs and other unnecessary unnatural treatments. The individual suffering from hemorrhoids benefits by being able to take a single natural tablet one to three times per day. Over-the-counter topical Preparation H® utilizes mineral oil (protectant), petrolatum (protectant), Phenylephrine (vasoconstrictor) and shark liver oil (protectant). Over-the-counter topical. Tucks® utilizes a combination of mineral oil (protectant), Pramoxine HCL (pain relief) and Zinc Oxide (protectant). Over-the-counter topical Balneol is essentially a moisturizer. Therefore, the active ingredients in most over-the-counter topical applications are utilized primarily to protect and treat pain in the area affected by hemorrhoids but do not effectively treat or prevent the hemorrhoids. Prescription drugs, like topical Analpram, utilize Pramoxine HCL (pain relief) and Hydrocortisone (steroidal anti-inflammatory), but still fail to treat hemorrhoids as well as the embodiments of the present invention. Another benefit to the over-the-counter natural tablet is that is can be used in conjunction with the gel/ointment described in co-pending patent application Ser. No. 12/______ and/or the soaking agent described in co-pending patent application Ser. No. 12/______. Any of the treatments alone or in combination facilitate the avoidance of expensive prescription drugs. In many instances today, patients are not able to afford prescription drugs. This is true for uninsured and insured patients given large deductibles and countless uncovered prescriptions. 
         [0013]      FIG. 1  depicts an ingredient list  100  for a first embodiment of the present invention. The three possible primary active ingredients comprise Bromelain  110 , Witch Hazel leaf  120  and Psyllium husk powder  130 . The Bromelain  110  and Witch Hazel leaf  120  have an anti-inflammatory effect while the Psyllium husk powder acts as a bulk laxative. When combined, the Bromelain  110 , Witch Hazel leaf  120  and Psyllium husk powder  130  have a synergistic effect as evidenced by the case studies detailed below. Alternatively, Bromelain alone can be used as the anti-inflammatory agent. 
         [0014]    Bromelain is a mixture of protein-digesting (proteolytic) enzymes found in pineapples. Bromelain, which is derived from the stem and juice of the pineapple, was first isolated from the pineapple plant in the late 1800s. Witch Hazel is a low growing shrub native to North America. Witch Hazel has many uses including as an anti-inflammatory, astringent, toner and numbing agent. Psyllium husk is the covering of seeds grown on the plant, Plantago Psyllium, which flourishes in the Middle East. Psyllium husk has been known to provide dietary fiber thus acting as a controlled bulk forming laxative. 
         [0015]    In a first embodiment, as depicted in the ingredient list  100  a tablet or tablet according to the embodiments of the present invention comprises 500 mg of Bromelain 1200 GDU  110 , 100 mg of Witch Hazel leaf  120  and 100 mg of Psyllium husk powder  130 . Additional, secondary ingredients in the tablet include Dicalcium Phosphate  140 , Cellulose  150 , Croscarmellose Sodium  160 , Stearic Acid  170 , Magnesium Stearate  180  and Silicon Dioxide  190 . Dicalcium Phosphate  140  is also known as Calcium Monohydrogen Phosphate and is a dibasic Calcium Phosphate. Dicalcium Phosphate  140  is a known tablet agent. Cellulose  150  (e.g., Hydroxyethyl Cellulose) is a nonionic polymer used as a thickening agent. Croscarmellose Sodium  160  is an excipient that acts as an inactive substance used as a carrier for the other active ingredients in the tablet. Stearic Acid  170  and Magnesium Stearate  180  (aka Octadecanoic Acid) are saturated fatty acids, and Silicon Dioxide  190  is another excipient. Those skilled in the art will recognize that other ingredients having the same properties may be used in place of, or in addition to, the aforementioned secondary ingredients. Also, certain of the listed secondary ingredients may be removed while maintaining the effectiveness of the tablet. The ingredients are combined into a pill or tablet form using conventional manufacturing techniques. 
         [0016]    In one embodiment, for active swelling, the tablets in accordance with the specifications listed above, are to be taken 3 times daily for 10 days. To handle flare ups, 1 tablet may be taken daily. Other treatment protocols may be possible with larger/smaller tablets. 
         [0017]    Table 1 details exemplary case studies. Advantageously, the results of utilizing the tablets in accordance with the embodiments of the present invention have dramatic synergistic effects over usage of the active ingredients individually. In addition, a high majority of the patients expressed that the tablets outperformed other over-the-counter medications such as common ointments. 
         [0000]    
       
         
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                   
                   
                   
                   
                   
                   
                 Tablet More 
                 Tablet 
               
               
                   
                   
                   
                   
                 Improvement 
                   
                 Effective Than 
                 Effectiveness 
               
               
                 Age 
                 Gender 
                 Diagnosis 
                 Symptoms 
                 Time 
                 OTC Products 
                 OTC Meds? 
                 0-5 
               
               
                   
               
             
             
               
                 81 
                 Female 
                 Hemorrhoids 
                 Swelling, Bleeding  
                  2 days 
                 Tucks 
                 Yes 
                 5 
               
               
                   
                   
                   
                 &amp; Pain 
                   
                   
                   
                   
               
               
                 60 
                 Female 
                 Hemorrhoids 
                 Swelling 
                  1 week 
                 Prep H 
                 Yes 
                 5 
               
               
                 62 
                 Female 
                 Hemorrhoids 
                 Swelling 
                  2 weeks 
                 Analpram 
                 Yes 
                 4 
               
               
                 57 
                 Male 
                 Hemorrhoids 
                 Itching 
                 N/A 
                 N/A 
                 No 
                 1 
               
               
                 N/A 
                 Male 
                 Hemorrhoids 
                 Swelling 
                 days 
                 Prep H 
                 Yes 
                 5 
               
               
                 78 
                 Male 
                 Hemorrhoids 
                 Bleeding &amp; Pain 
                  2 weeks 
                 Analpram 
                 Yes 
                 3 
               
               
                 80 
                 Male 
                 Hemorrhoids 
                 Swelling &amp; Pain 
                  2 or more days 
                 Prep H 
                 Yes 
                 5 
               
               
                 39 
                 Female 
                 Hemorrhoids 
                 Bleeding &amp; 
                 10 days 
                 Prep H 
                 Yes 
                 5 
               
               
                   
                   
                   
                 Itching 
                   
                   
                   
                   
               
               
                 59 
                 Female 
                 Hemorrhoids 
                 Swelling 
                  2 days 
                 Prep H 
                 Yes 
                   
               
               
                 N/A 
                 N/A 
                 Hemorrhoids 
                 Swelling 
                  7 days 
                 Prep H 
                 Yes 
                 5 
               
               
                 N/A 
                 N/A 
                 Hemorrhoids 
                 Swelling, Bleeding 
                  2 weeks 
                 Prep H 
                 Yes 
                 4 
               
               
                   
                   
                   
                 &amp; Pain 
                   
                   
                   
                   
               
               
                 N/A 
                 N/A 
                 Hemorrhoids 
                 Swelling 
                  7 days 
                 Prep H 
                 Yes 
                 5 
               
               
                 47 
                 Male 
                 Hemorrhoids 
                 Swelling, Bleeding, 
                  2 days 
                 Tucks, Prep H 
                 Yes 
                 5 
               
               
                   
                   
                   
                 Pain &amp; Itching 
                   
                   
                   
                   
               
               
                 63 
                 Female 
                 Hemorrhoids 
                 Swelling, Bleeding, 
                  2 days 
                 Tucks, Prep H 
                 Yes 
                 5 
               
               
                   
                   
                   
                 Pain &amp; Itching 
                   
                   
                   
                   
               
               
                 45 
                 Female 
                 Hemorrhoids 
                 Bleeding &amp; Pain 
                  3 days 
                 Tucks, Prep H 
                 Yes 
                 5 
               
               
                 N/A 
                 N/A 
                 Hemorrhoids 
                 Swelling &amp; Bleeding 
                  2 weeks 
                 N/A 
                 Yes 
                 5 
               
               
                 N/A 
                 Male 
                 Hemorrhoids 
                 Bleeding 
                  2 or more days 
                 Prep H 
                 Yes 
                 5 
               
               
                 61 
                 N/A 
                 Hemorrhoids 
                 Swelling 
                  1 week 
                 N/A 
                 Yes 
                 4 
               
               
                 80 
                 Female 
                 Hemorrhoids 
                 Swelling 
                  3 weeks 
                 N/A 
                 Yes 
                 3 
               
               
                 80 
                 Male 
                 Hemorrhoids 
                 Swelling &amp; Pain 
                 10 days 
                 Prep H 
                 Yes 
                 5 
               
               
                 66 
                 Male 
                 Hemorrhoids 
                 Swelling 
                  7 days 
                 Prep H 
                 Yes 
                 5 
               
               
                 66 
                 N/A 
                 Hemorrhoids 
                 Swelling 
                  7 days 
                 Prep H 
                 Yes 
                 4 
               
               
                   
               
             
          
         
       
     
         [0018]    Table 1 lists the age and gender of a majority of patients. Also shown in Table 1 are the diagnosis, symptoms, time for results, over-the-counter medications used by the patients, each patient&#39;s opinion of whether the tablets have better results than the over-the-counter medications and a rating score of effectiveness associated with the tablets. Table 1 evidences that the tablets treat the typical symptoms namely swelling, bleeding, pain and itching associated with hemorrhoids. Positive results from the tablets were felt in a range of 2 days to 3 weeks. And, except for 1 patient, each patient opined that the tablets treated hemorrhoids better than over-the-counter medications (e.g., Preparation H® (Prep H), Tucks®, Analpram and Balneol®). In addition, the patients rated the treatment as an average of 4.45 out of 5 on the ratings scale. Such feedback, including the average rating, evidences a dramatic effect associated with the ingredients in the tablet form. 
         [0019]      FIG. 2  shows a flow chart  200  detailing a method of treating hemorrhoids using the tablets. At  205 , hemorrhoids is diagnosed. At  210 , it is determined whether the patient has active swelling or a flare up. If the patient has active swelling, at  215 , the patient is instructed to take 3 tablets per day for 10 days. If the patient has a flare up, at  220 , the patient is instructed to take a tablet daily until the hemorrhoid symptoms dissipate. 
         [0020]      FIG. 3  shows a form  300  for constructing a box to hold a kit comprising individual containers for each of the soaking agent  305  (described in co-pending patent application Ser. No. 12/______), tablets  310  and gel/ointment  315  (described in co-pending patent application Ser. No. 12/______). Separately or alone, the soaking agent, tablets and gel/ointment effectively treat hemorrhoids. The treatment protocols for each delivery vehicle remain the same when each is used in combination as when used individually. In other words, all three treatment protocols can be used simultaneously without any negative side effects. 
         [0021]    Although the invention has been described in detail with reference to several embodiments, additional variations and modifications exist within the scope and spirit of the invention as described and defined in the following claims.