Summary of clinical trial

The study was aimed to clinically validate the efficacy of three source drugs of Trivrut Operculina  turpethum, Operculina petaloidea and Marsdenia tenacissima  in the management of Purishaja Anaha constipation. For this, a randomized double blind comparative clinical study on 90 patients of clinically diagnosed cases of Purishaja Anaha constipation was conducted. Root bark powder of each drug in the dose of 5 g was administered with sugar and hot water in the morning for 3 days and observations were note down in specially design clinical research proforma and follow up was taken after seven days.

Observation

Total 90 patients were registered in the present study, among them 30 patients were enrolled in Group A, B and C respectively. All the patients completed the treatment procedure. 38.89percentage were in the age group of 31 to 40 years, 52.22percentage were female, 78.89percentage patients were of Hindu religion, 86.67 percentage were married, 95.56 percentage were educated 27.78 percentage were housewives and labor class;56.67 percentage patients were from upper middle class UMC, 64.44percentage patients were taking vegetarian diet. Habit of tea was observed in 100percentage of the patients whereas outside food was observed in 84.44percentage of the patient. Addiction of tobacco chewing and smoking was observed in 21.11percentagepatients.73.33percentage patients were consuming Samyakasufficientamount of food. 83.33percentage patients were habituated with Viruddhashana.81.11percentage patients were drinking water in proper quantity. 46.67 percentage patients were having sound sleep, 54.44percentage patients were doing mild physical work, 54.44 percentage patients had the habit of Vegavidharanasuppression of natural urges, Chinta tension was present in 65.56percentage patients whereas Krodhaanger was present in 55.56percentage. VataPittaPrakritiwas present in 68.89 percentage patients and 22.22 percentage patients were of VataKaphaPrakruti.77.78percentage of the patients were having MadhyamaAbhyavaran Shakti medium power of ingestionwhereas 53.33percentage of the patients were having MadhyamJaranashaktimedium power of digestion 54.44 percentage patients were having Mandagni poor digestive fireand 45.56 percentage patients were having Vishamagni. 51.11percentage patients were having MadhyamaKoshthamedium formed bowel tendency, whereas 38.89percentage patients were having KruraKoshthahard bowel tendency.

NidanaEtiological factorsAccording to above data,AtikatuSpicy foodRasasevana andViruddhashanaincompatibledietwas found as the cause for Purishaja Anaha in 87.78percentage and 80percentage of the patients respectively. Atishitasevanacold and Atirukshabhojanadrydietary items were observed as the cause in 62.22percentage and 34.44percentage of the patients respectively. 47.78percentage of the patients were having Vishamashanafood taken at unusual timeandas cause for the disease whereas Adhyashanafood taken just after ingestion of previous foodwas seen as the cause for Purishaja Anaha in 30percentage of the patients. In the present study it was observed that 78.89percentage patients were having Divaswapasleep during day time as a cause for the disease, whereas Vegavidharana suppression of natural urgeswas found in 53.33percentage of the patients. Ratrijagaranaawake at nightand Atichankramanaroamingwere causative factors in 12.22percentage and 11.11percentage of the patients respectively. Chinta stress and Krodhaanger were observed as ManasaNidana psychological factors in 66.67percentage and 56.67percentage patients respectively.

Result

Effect of Therapy

After the treatment in Group A;  maximum improvement was noticed in PurishaApravartanai.e. 68.96percentage, Adhmana 59.57percentage, Katiprushthashula 20.68percentage; Katiprushthastambha  21.05percentage; Udargaurva 54.05percentage; Pindikodweshtana 47.61percentage; Shirashula 72.41percentage.

After the treatment in Group B maximum improvement i.e. 70.31percentage, was noticed in Purishaapravartana, Adhmana 60.42percentage, Katiprushthashula45percentage; Katiprushthastambha  37.04percentage; Udarshula 33.33percentage, Udargaurva 40.48percentage; Pindikodweshtana 55percentage; Shirashula 70.27percentage.

After the treatment in Group C maximum improvement was noticed in Udarshula 68.75percentage, followed byShirashula 50percentage, Adhmana 42.85percentage, Purishaapravartana 34.92percentage, Katiprushthashula 10.52percentage, Katiprushthastambha  13.33percentage; Udargaurva 25percentage; Pindikodweshtana 25percentage.

Assessment of drug for purgative action

In the assessment criteria of the efficacy of the drugs, it was observed that in 30percentage of the patients in both Group A and B; defecation was started within 5 hours after intake of drug. In 93.33percentage of the patient, defecation was started after 12 hr of medication in group C. In group A, 53.3percentage of the patients reported more than 5 Vegas with watery and mucus stool consistency. In group A, 53.3percentage, 66.7percentage and 46.7percentage of the patients reported more than 5 Vegas with watery and mucus stool consistency and general debility respectively after evacuation  whereas it was 43.3percentage ,46.7percentage and 60percentage respectively in group B. In the patients treated with group C showed presence of 12 Vegas in 90percentage, normal consistency of stool in 100percentage and unsatisfied feeling in 63.33percentage.

Undesirable effects of the drugMaximum 100percentage of the patient treated with group A and Group B reported Udarshula. Kanthakarshanawas observed in53.33percentage and 33.3percentage of the patients respectively in group A and Group B. In group C, only Chhardi was reported in 36.67percentage of the patients

Overall effect of therapy

None of the patients in the three groups got complete remission. Marked improvement was found in 3.33percentage patients in group A and C. There was no marked improvement in B group.Moderate improvement was found in 36.67percentage in patients treated with Group B, and 26.67percentage patients in Group A. None of the patient from Group C got moderate improvement.Mild improvement was found in 70percentage patients in Group A, 56.67percentage patients in Group B, and 33.33percentage patients in Group C.63.33percentage patients from group C, whereas 3.33percentage from both group A and B remained unchanged.

Follow up

It was observed that 56.67percentage of patients from group A and B got recurrence of complaints while 93.33percentage of patients from group C reported recurrence of compliant after the follow up of seven days.Blinded drug were identified as O turpethum, O petaloidea and M tenacissima for Group A Group B and Group C respectively.