CLINICAL RESEARCH REPORT – TO EVALUATE THE EFFICACY AND SAFETY OF RENTONE CAPSULE IN THE MANAGEMENT OF RENAL CALCULI
Sponsored by – Ayush Herbs Nag Rota Himachal Pradesh
Under Principal Investigator – Dr. Sunil Thakur M.D. (Ayu.), Lecturer – P.G. Dept. of Kayachikitsa R.G.G.P.G.Ayu. College, Paprola, Kangra H.P. – 176115
CLINICAL TRIAL REPORT
Download pdf Clinical Trial Report of Evaluating the Efficacy and Safety of Rentone Capsule in the Management of Renal Calculi
Ayurveda, the system of Indian medicine and science of life, deals with the well being of mankind. Renal stones are known to mankind since times immemorial. Clinical features of the disease are described even in Vedas, the oldest repositories of human knowledge. In Ayurvedic texts the etiological factors, classification, symptomatology, pathology, complications and its management are described in a most scientific manner. This disease is dreadful and hence considered one of the Mahagadas due to its potentiality to disturb anatomy and physiology of urinary system.
Further according to modern science the formation of stone in the urinary system is one of the main problems of urology. The cause and mechanism of their formation is still uncertain. Furthermore renal stones occur in both sexes at all the ages but commonly in the 3rd and 4th decade.
The age prevalence rate in India ranges around 3.4% at mean age group of 30-40 years. It is an agonizing complex disorder presenting with severe colicky pain radiating to loin, to groin, burning micturition, dysuria etc.
Current research proposal is a small step to explore evidence based therapeutic potential of Ayurvedic Herbal formulation.
Present short term clinical trial is designed to evaluate efficacy of Rentone capsule, when used in a dose of 2 capsule twice a day in volunteers.
The trial formulation Rentone capsule is a partialy organic herbal preparation of AYUSH Herbs, Nagrota and is taken for clinical trial under P.G. department of Kayachikitsa R.G.G.P.G.Ayurvedic College Paprola.(H.P.)
AIMS AND OBJECTIVES
- To evaluate the efficacy of Rentone Capsule in management of Renal Stones.
- To evaluate the safety of drugs.
MATERIAL AND METHOD
The study was conducted in compliance with good clinical practice (GCP) guidelines and other applicable regulations.
25 volunteers from OPD and IPD of Kayachikitsa department of KG.G.P.G. Ayu.College and Hospital Paprola fulfilling the criteria irrespective of their age, sex, religion etc.
Patients were selected between age group of 18 – 65 years. Routine blood examination carri<;:d out in order to rule out any other pathology and monitor their normal value of blood. Trial Subjects were detailed about nature of trial and informed consent was obtained.
- Inclusion criteria:
- a. Patients of either sex, age 18 – 65 years.
- b. All the patients suffering from renal calculus having < 10mm. size in any part of urinary system.
- c. Patients who are not interested to undergo for surgery or which are unfit for surgical intervention.
- Exclusion criteria:
- a. Patients not willing for trial.
- b. Pyelonephritis.
- c. Patients with obstructive uropathy.
- d. Patients with known metabolic/endocrinal disorder favouring calculus formation.
- e. Patient with impaired renal function or any severe complication.
- f. Patients with evidence of malignancy.
- g. Patient with poorly controlled diabetes mellitus, patients on prolonged (>6 weeks) medication with corticosteroids, antidepressants, anticholinergic etc. or any other drug that may have an influence on the outcome of study.
- h. Patients with concurrent serious hepatic disorders.
- i. Patients with severe pulmonary dysfunction.
- j. Patients with advanced chronic disease.
METHOD OF STUDY
DURATION OF TRIAL
PERIOD OF CLINICAL STUDY:
Start date: December 2014
Completion date- July 2015
The study was done in single trial group. It was open trial with voluntary participation of subjects.
STUDY, VISITS & ASSESSMENT
The subjects visited the hospital at screening & enrollment and after 15 days of trial period. Following investigations were done before and after trial to exclude pathology
- Routine blood examination (Hb, TLC, DLC, ESR) Blood sugar (FBS)
- Blood sugar (FBS)
- RFT (B. Urea & S. creatinine)
- Urine examination (routine & Microscopic)
OBSERVATIONS & RESULTS
|Observations & Results|
|Total number of patients registered||25|
|Total number of patients completed trial||20|
|Dropout from the study||5|
In the present study, total 25 patients were registered out of which 20 patients completed the study and 05 patients did not complete the whole duration of the trial. The clinical and laboratory profiles of 20 patients are presented here.
SIGNS & SYMPTOMS OF RENAL CALCULI (MUTRASHMARI) OBSERVED IN 20 PATIENTS
TABLE NO. 22
|Signs & Symptoms||No. of Patients||%age|
|Pain (Nabhi & Basti Vedana)||20||100|
|Dysuria (Mutradhara Sanga)||4||20|
|Tenderness at renal angle (Sevani Vedana)||7||35|
|Haematuria (Sarudhira Mutrata)||1||5|
|Pyuria (Ati Avilamutrata & Gomeda Prakasham)||2||10|
The distribution of patients based on clinical features indicate that all the 20 patients of renal calculi were having the pain (100%) and (40%) patients were having burning micturition, (20%), (35%), (5%) and (10%) patients were having dysuria, tenderness at renal angle, Haematuria, Pyuria respectively.
- Pain (Nabhi & Basti Vedna) – The mean score of Pain was 2.90 before treatment which decreased to 1.10 after treatment. The percentage difference before and after treatment was (62.06%) which is statistically highly significant. (p < 0.001) .
- Burning Micturition – The mean score of Burning micturition was 1.10 before treatment and 0.40 after treatment showing (63.63%) relief which is significant statistically (p < 0.05).
- Dysuria (Mutradhara Sanga) – The mean score of Dysuria (Mutradhara Sanga) was .50 before treatment and it is reduced to .05 after treatment with (90%) relief. The result is significant (p < 0.05).
- Tenderness at renal angle (Sevan; Vedana) – The mean score of Tenderness at renal angle (Sevani Vedana) was 0.80 before treatment and it came down to 0.00 after treatment with (100 %) relief. The result is significant (p < 0.05).
- Haematuria (Sarudhira Mutrata) – The mean score of Haematuria (Sarudhira Mutrata) was 0.05 before treatment and it is reduced to .00 after treatment, giving (100%) change which is statistically insignificant i.e. (p > 0.05).
- Pyuria (Ati avlamutrata & Gomeda Prakasham) – The mean score of Pyuria (At; avilamutrata & Gomeda Prakasham) was 0.10 before treatment and came down to 0.00 after treatment showing (100%) relief which is statistically insignificant (p > 0.05).
OVERALL EFFECT OF THERAPY ON TOTAL NUMBER OF CALCULI IN 20 TRIAL PATIENTS
Total 44 calculi observed in 20 patients. Overall effect of trial showed (52.27 %) calculi were expelled out, decreased in size of calculi in (11.36%), increase in size in (0%) and (36.36%) having shown no change in sizes of calculi.
OVERALL EFFECTS OF THE THERAPY
Out of 20 patients, 8 patients (40%) were markedly improved with ≥ 75% relief with respect to symptomatology and laboratory parameters. 6 patients (30%) were moderately improved with ≥ 50% relief as far as symptomatology was concerned ,3 patients were mildly improved and 3 patients remains unimproved as for as symptomatology and laboratory parameters were concerned.
The patients of all ages and both the sex groups reported improvement in their complaints.
No side/adverse effect found in any patient.
EFFECT OF THERAPY ON HAEMATOLOGICAL AND BIO-CHEMICAL PROFILE
Patients who completed the trial showed that in Haematological profile; Haemoglobin & ESR of patients were within the normal limit both before and after the treatment and statistically significant. TLC & DLC were within normal limits both before and after the therapy and statistically insignificant changes were observed in these values after the completion of therapy. In biochemical profile FBS statistically significant and blood urea, serum creatinine were within normal limits both before and after the therapy statistically insignificant changes were observed in these values after the completion of therapy.
In spite of detailed classical study and experimentation in various ways, a theory is accepted only after the proper reasoning of observation. Hence, discussion is very important part of any scientific research.
The present clinical research work entitled: “To Evaluate the Efficacy and Safety of Rentone Capsule in the Management of Renal Calculi” has been undertaken to reveal the effectiveness of an Ayurvedic formulation specially made on the basis of requirement for the breakdown of the pathogenesis of urinary calculus.
- Urolithiasis is the third most common disease of the urinary tract followed by UTI and BPH.
- It usually occurs in middle life during the most productive years, causes pain, loss of working, time, medical expense and need to hospitalize and also an important cause of renal failure.
- Ashmari description is the specific contribution of Acharya Sushruta and he included it in the EIGHT MAHAGADA (Su. Su 33/4),
- The clear cut cause of the disease is still unknown. But in Ayurveda, Kapha dosha in increased quantity has been accepted as the main reason for the formation of Mutrashmari.
- According to modem science the formation of stone in urinary system is one of the main problems of the urology. The causes and mechanism of their formation is still obscure but various factors like age, sex, irregular food habits, metabolic disorders, sedentary life style, occupation, hydration status, nutritional deficiency & geography etc. may be responsible for the formation of stone.
SIGNIFICANCE OF HERBAL THERAPY
The treatment of renal calculi is mainly considered with dissolution of existing stones and preventing the recurrence of stones. (DODOALA et.al. 2010)
Standard pharmaceutical drugs used to prevent and cure urolithiasis are not effective in all the cases, costly, quite common recurrences ,risks of long term fertility potential side effects and no gurantee. References prove that litholytic herbs for treatment of renal stones are used since ancient periods before inventing modern treatments. (Surendra K.Pareta et.al.20 11 ).Herbal drugs are reported to be effective with no side effects. The drug for prevention of the disease or its reoccurrence is of great interest as no drug in clinical therapy is of satisfactory result (Soundarajan et.al.2006).The ingredients which are used in Rentone capsule have potent litholytic property.
- Acyranthus aspera have shown potent litholytic property (Anshu aggarwal et.al.,2010)
- Dolichous biflorus (Rana Gopal Singh et.al. 2010)
- Rubia cordifolia (Kalyani Divakar et.aI2010)
- Didymocarpus pedicellata Roxb.(Amrit Pal Singh et.al.,2007)
- Tribulus terrestris (Satish et.al 2010) (Innovative drug discovery -A potential herbal wealth with liholytic activity www.ijidd.com)
- Saxifraga linguata commonly known as saxifrages or stone breakers and having litholytic property (www.diomedia.com)
- Ocimum basilicum beisng detoxifier and mild diuretic in nature, can help reduce uric acid level concentration in blood as well as helps cleaning of the kidneys through urination. It has painkiller effects and help bear the pain from kidney stones. (ayurveda foryou.com)
The drug “Rentone capsule” was found to have significant effect on pain, burning micturition and dysuria & also in decreasing sizes of stones due to its lithotryptic action. Drug has also significant effect on the signs/symptoms due to its anti-inflammatory, antispasmodic actions. It also helps in flushing out of calculus of small sizes mainly ureteric calculus due to its diuretic effects.
Observations obtained from the present study had shown no side effects of the drugs.
However the present study was conducted for short duration of time (45 days). So it may require further study for longer duration of time to get more better results.
So it can be concluded that “Rentone capsule” was found to be effective in treating renal calculi.
- Innovative drug discovery-a potential wealth with litholytic activity.
- www.phytojournal.com – Anti urolithiatic activity of Dolichous biflorus.
- Ayurveda foryou . com
- Sushruta Samhita sutra sthana 33/4.
- Acyranthus aspera -potent herballitholytic activity.
- Anshu Aggrwal A ,Tandon S ,Singla SK,Tandon C .Reduction of oxalate induced renal tubular epithelial cell injury and inhibinition of calcium crystallization in vitro by aqeous extract of Acyranthus aspera.lnt j green pharma.4,2010 159-64
- Rana Gopal Singh, Sanjeev Kumar Behura, Rakesh Kumar, Litholytic Propery of Kulattha (Dolichous Biflorus) vs Potassium Citrate in Renal Calculus Disease: A comparative study. JAPI, 58, 2010, 287.
- Amrit Pal Singh, Didyymocrpus pedicel lata : The Lithontriptic Ethnomedicine. Ethmnobotanical Leaflets, 11, 2007, 73-75.
- Satish H. Raman D, Kshama D, Shivananda BG, Shridhar KA. Study the relative effect of spironolactone and different solvent extract of Tribulus terrestrison urolithiatic rats. Phcog Mag, 5, 2009, 83- 9