Clinical evaluation of different varieties of Trivrut on Constipation
- Conditions
- suffering from Constipation
- Registration Number
- CTRI/2014/10/005119
- Lead Sponsor
- NA
- Brief Summary
**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 *Samyaka*sufficientamount 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 *Vegavidharana*suppression of natural urges*, Chinta* tension was present in 65.56percentage patients whereas *Krodha*anger was present in 55.56percentage. *VataPittaPrakriti*was 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 *MadhyamJaranashakti*medium 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 *MadhyamaKoshtha*medium formed bowel tendency, whereas 38.89percentage patients were having *KruraKoshtha*hard bowel tendency.
***Nidana***Etiological factorsAccording to above data,*Atikatu*Spicy food*Rasasevana* and*Viruddhashana*incompatibledietwas found as the cause for *Purishaja Anaha* in 87.78percentage and 80percentage of the patients respectively. *Atishitasevana*cold and *Atirukshabhojana*drydietary items were observed as the cause in 62.22percentage and 34.44percentage of the patients respectively. 47.78percentage of the patients were having *Vishamashana*food taken at unusual timeandas cause for the disease whereas *Adhyashana*food 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 *Divaswapa*sleep during day time as a cause for the disease, whereas *Vegavidharana* suppression of natural urgeswas found in 53.33percentage of the patients. *Ratrijagarana*awake at nightand *Atichankramana*roamingwere causative factors in 12.22percentage and 11.11percentage of the patients respectively. *Chinta* stress and *Krodha*anger 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 *PurishaApravartana*i.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, Katiprushthashula*45percentage*; 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 by*Shirashula 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*. *Kanthakarshana*was 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Patients with classical symptoms of Purishaja Anaha Patients having complaints of irregular and unsatisfactory bowel motions will be selected irrespective of sex religion from OPD of dravyaguna department.
Patients suffering from any systemic disease like Hypertension Diabetes TB etc Pregnant woman Patients unsuitable for virechana.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method everyday,In the frequency and consistency of stool Baseline and every day for 7 days
- Secondary Outcome Measures
Name Time Method Symptomatic relief in associated symptoms of constipation 3 days
Trial Locations
- Locations (1)
Dravyaguna OPD No 17
🇮🇳Jamnagar, GUJARAT, India
Dravyaguna OPD No 17🇮🇳Jamnagar, GUJARAT, IndiaRasika kolhePrincipal investigator9374333651dr.rasika_kolhe@yahoo.com