Clinical study on Ayucid Capsules in Acidity patients
- Conditions
- Gastro-esophageal reflux disease without esophagitis,
- Registration Number
- CTRI/2018/01/011260
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
**Brief Methodology:**
It is an Open Label, Randomized, Comparative, Multicenter,Prospective, Clinical Study to evaluate efficacy and safety of Ayucid Capsulesand Omeprazole (20 mg) in Patients Suffering from Chronic symptomaticGastro-esophageal Reflux Disease (GERD). The study will be conducted in 60patients at three sites in India. Subjects from group A will be advised to takeAyucid Capsules in a dose of 2 capsules twice daily, orally before meals withwater for 28 days. Subjects from group B will be advised to take CapsuleOmeprazole 20 mg once daily before lunch with water for 28 days. Primaryoutcome of the study would be to assess complete resolution of heartburn in two groups on Day -3, Day 0, Day7, Day 14, Day 21 and Day 28. Secondary outcomes of the study would be toassess effect of Ayucid Capsule and Omeprazole on other symptoms of GERD, i.e.,acid regurgitation, dysphagia, epigastric pain, and nausea, to assessrequirement of rescue medication (antacid) use each day through diary card intwo study groups, to assess quality of life (QOL) on GERD - Health Related QOLQuestionnaire (GERD HRQL) in the two study groups, to assess other digestionrelated symptoms in the two study groups, to assess safety based on clinicaladverse events and laboratory test results in the two study groups and toassess overall improvement by subject and investigator at the end of studytreatment.
**Results:**
A total of 91 subjects were screened inthe study. There were 16 screen failures as they did not meet inclusion /exclusion criteria. Of these subjects, 75 subjects were randomized into twogroups. There were 12 dropouts in the study, which were due to reasons otherthan occurrence of adverse events (did not provide follow up). A total of 63subjects were considered as completers or efficacy evaluable cases, 33 subjectswere in Ayucid Group and 30 subjects were in Omeprazole 20 mg Group. All the subjects who took even a single doseof any study drug were considered for safety evaluation.
Of the 33 subjects in Ayucid group,there were 15 males and 18 females. Out of the 30 subjects in Omeprazole group,there were 11 males and 19 females. The average age of subjects in the AyucidGroup was 45.70 ±9.41 years while in the Omeprazole Group it was 39.73 ±9.02years. There was no significant difference in the age of subjects in the twostudy groups.
In the Ayucid group it was observedthat there was 1 subject of Pittaja and Vata-Kaphaja Prakruti each, 2 subjectsof Kapha-Pittaja Prakruti, 7 subjects of Pitta-Kaphaja Prakruti, 8 subjects ofPitta Vataja Prakruti and 14 subjects of Vata- Pittaja Prakruti. In Omeprazolegroup it was observed that there were 4 subjects of Vata-Kaphaja Prakruti, 2subjects of Kapha-Pittaja Prakruti, 5 subjects of Pitta-Kaphaja Prakruti, 7subjects of Pitta Vataja Prakruti and 12 subjects of Vata- Pittaja Prakruti.
At the end of28 days of study subjects were evaluated for complete resolution of theiroccurrence of heart burn. There was complete resolution of heart burn in 14subjects (42.42%) in Ayucid group while the same was observed in 17 subjects(56.66%) in Omeprazole group. It was observed that there was no significantdifference between the two groups i.e. the effect in both the groups was equal.
In Ayucid group, there were 6 (18.18%) subjects whoexperienced complete absence of heart burn on day 7. On day 14 and 21, therewere 5 (15.15%) and 11 (33.33%) subjects who experienced complete resolution ofthe heart burn respectively. In Omeprazole group, 9 (30%), 10 (33.33%) and 10(33.33%) subjects experienced complete resolution of heart burn on day 7, day14 and day 21 respectively.
It wasobserved that there was a significant reduction in the severity of heart burnfrom baseline to each follow up visits in both the groups starting from day 7.The baseline score of severity of heart burn in Ayucid group was 2.33 ±0.54which reduced significantly to 1.25 ±0.88 on day 7. The mean score of severity ofheart burn reduced further to 1.17 ±0.71 and 0.79 ±0.73 respectively on day 7and 14. At the end of the study the mean score of severity of heart burn was0.58 ±0.50. In Omeprazole group, the mean score of severity of heart burn was 2.17±0.59 at baseline which reduced significantly to 0.92 ±0.86 at the end of 7days. The mean score of severity of heart burn further reduced to 0.72 ±0.68, 0.52±0.51 and 0.43 ±0.50 on day 14, 21 and 28 respectively. There was nosignificant difference between the two groups at all the follow up visits i.e.between groups effects were equal.
At baseline visit, the mean score forseverity of acid regurgitation in Ayucid group was 1.76 ±0.87, which reduced significantly to 1.03 ±0.86 on day 7. The mean score for severity of acid regurgitation furtherreduced significantly to 0.76 ±0.74on day 14, 0.62 ±0.56 on day 21and 0.39 ±0.50 on day 28. Themean score of severity of acid regurgitation in Omeprazole group was 1.80 ±0.80 at baseline, which reducedsignificantly to 0.80 ±0.76 onday 7. The mean score for severity of acid regurgitation reduced significantly to0.56 ±0.58 on day 14, 0.48 ±0.51 on day 21 and 0.23 ±0.43 on day 28. There was nosignificant difference between the two groups at baseline and on each follow upvisits i.e. between groups effects wereequal.
The mean score for severity ofdysphagia in Ayucid group was 0.97 ±1.02on baseline visit, which reduced to 0.66 ±0.90 at the end of 7 days. The mean score for severity of dysphagia furtherreduced to 0.34 ±0.67, 0.24 ±0.44 and 0.09 ±0.29 on day 14, day 21 and day 28 respectively. These reductionswere found to be significant at all follow up visits as compared to itsbaseline. The mean score for severity of dysphagia in Omeprazole group was 1.03±0.85 at baseline visit, whichreduced significantly to 0.48 ±0.71on day 7. The mean score for severity of dysphagia further reduced to 0.20 ±0.41 on day 14, 0.10 ±0.30 on day 21 and 0.03 ±0.18 on day 28. There was nosignificant difference between the two groups at baseline and on each follow upvisits i.e. between groups effects wereequal.
The meanscore of severity of epigastric pain in Ayucid group was 0.97 ±1.02 on baselinevisit, which reduced significantly to 0.59 ±0.87 on day 7. The mean score ofseverity of epigastric pain further reduced to 0.48 ±0.63 on day 14, 0.24 ±0.44on day 21 and 0.21 ±0.42 on day 28. In Omeprazole group, the mean score ofseverity of epigastric pain was 0.87 ±0.82 on baseline visit, which slightlyand insignificantly reduced to 0.80 ±0.82 at the end of 7 days. The reductionwas found to be significant on day 14 (0.20 ±0.41). The mean score of severityof epigastric pain reduced significantly to 0.29 ±0.46 and 0.17 ±0.38 on day 21and 28 respectively. The difference between the two groups was however found tobe statistically non-significant i.e. between groups effects were equal.
In Ayucid group, the mean score of nauseawas 1.06 ±0.61 at baseline visitwhich reduced significantly to 0.72 ±0.81on day 7. The severity further reduced to 0.41 ±0.57 on day 14, 0.34 ±0.48on day 21 and 0.36 ±0.55 on day28. In Omeprazole group, the reduction in this symptom was also found to besignificant from day 7 and continued further till the end of the study. Themean score of nausea at baseline was 1.07 ±0.83 which reduced significantly to 0.64 ±0.86, 0.28 ±0.52,0.14 ±0.36 and 0.13 ±0.35 on day 7, day 14, 21 and 28respectively. On analysis between the two groups the difference in reductionwas not found to be significant i.e.between groups effects were equal.
The meanappetite score at baseline was 5.12 ±1.34 which improved significantly to 5.50±1.18 on day 7. The mean appetite score further improved to 6.57 ±1.32 on day14. The mean appetite score was found to be 7 ±1.52 and 7.20 ±1.55 on day 21and 28 respectively. In Omeprazole group, the mean appetite score was found tobe 4.73 ±1.39 at baseline visit which increased significantly to 5.72 ±1.54 onday 7, 6.06 ±1.54 on day 14, 6.93 ±2.14and 7.75 ±2.27 on day 21 and 28 respectively.
It was observed that only one subjectin Ayucid capsule group required the use of rescue medication only once duringthe study period.
The mean total heartburn score atbaseline in Ayucid group was 13.36 ±7.24,which reduced significantly to 5.69 ±5.50and 2.81 ±2.83 on day 14 and day28 respectively. In Omeprazole group, the mean total heartburn score atbaseline visit was 12.90 ±7.37which reduced to 4.32 ±4.94 and2.14 ±2.12 on day 14 and 28respectively. The difference between the two groups was however found to be non-significanti.e. between groups effects were equal.
The mean totalregurgitation score at baseline visit in Ayucid group was 10.58 ±7.38 whichreduced significantly to 4.24 ±4.85 and 1.7 ±2.67 on day 14 and 28 respectively.The mean total regurgitation score at baseline visit in Omeprazole group was11.47 ±7.93 which reduced significantly to 3.60 ±4.98 and 1.79 ±2.35 on day 14and 28 respectively. The difference between the two groups was however found tobe non-significant i.e. between groups effects were equal.
Assessment oftotal GERD-HRQOL score was done and it was observed that there was asignificant reduction in the same in both the study groups when compared to itsbaseline score. The difference between the two study groups was found to benon-significant. The mean total GERD-HRQOL score in Ayucid group was 26.48 ±16.60which reduced significantly to 10.93 ±11.29 and 5 ±5.26 on day 14 and 28 respectively.The mean GERD-HRQOL score at baseline visit in Omeprazole group was found to be27.10 ±18.44 which reduced to 8.84 ±11.19 and 4.18 ±4.35 on day 14 and 28 respectively.
It wasobserved that 21 (63.63%) subjects had bloating at the baseline visit in Ayucidgroup, while on day 14 and 28 only 13 subjects (39.39%) and 12 subjects(36.36%) complained of this symptom respectively. In Omeprazole group, 17(56.66%) subjects were having bloating at baseline visit. There were 13(43.33%) and 9 subjects (30%) who complained of bloating on day 14 and 28respectively. The difference between these two groups was found to be non-significant.
It was observedthat at the baseline, 18 (54.54%) subjects had constipation in Ayucid group.There were 9 (27.27%) and 8 subjects (24.24%) who had constipation on day 14and 28 respectively. In Omeprazole group, 15 (5-%) subjects had constipation atthe baseline visit. There were 7 (23.33%) subjects who had constipation on day14 and 28. There was no significant difference between the two groups.
It wasobserved that a total of 29 (87.87%) subjects had gaseous abdominal distensionat the baseline visit in Ayucid group. There were 19 (57.57%) and 15 (45.45%) subjectswho reported to have gaseous abdominal distension on day 14 and 28 respectively.In Omeprazole group, gaseous abdominal distension was observed in 25 subjects (83.33%0at baseline visit. On day 14, 12 subjects reported to have gaseous abdominaldistension and at the end of the study 10 (33.33%) subjects reported to have gaseousabdominal distension. There was no significant difference between the twogroups.
Nosignificant change in any of the laboratory parameters and ECG was observed frombaseline to 28 days in both the study groups. The parameters were observed tobe within normal limits both at the baseline and final study visits.
Vitalparameters like pulse rate, respiratory rate, blood pressure and bodytemperature were checked at all the visits. It was observed that there was nosignificant change in these parameters on all the visits. These parameters werewithin normal range at baseline as well as on each follow up visit.
A total of 39AEs were reported by 25 subjects. Of these 26 AEs were reported in Ayucid groupwhile 13 AEs were reported in Omeprazole group. Of the 26 AEs reported inAyucid group, 20 AEs were not related to the study drug, while 5 AEs werepossibly related to the study drug. These episodes did not require interruptionof the study drug or procedure. Out of these, one adverse drug reaction(allergic rash) was found in one subject which was definitely related to thestudy drug. Also of the 13 AEs reported in Omeprazole group, 11 AEs werereported as unrelated to the study drug, while 1 AE each was reported aspossible and probably related to the study drug. These episodes did not requireinterruption of the study drug or procedure.
It wasobserved that 29 (87.87%) subjects reported of much to very much improvement inAyucid group while 22 (73.33%) subjects reported much to very much improvementin omeprazole group. Two subjects (2.06) reported minimal improvement in Ayucidgroup while 5 (16.66%) subjects reported minimal improvement in Omeprazolegroup at the end of the study.
**Conclusion:**
It can beconcluded from the results that both Ayucid and Omeprazole capsules have shownsignificant improvement in the symptoms of GERD like heartburn, acid regurgitation,nausea, epigastric pain etc. The improvement in both the groups was evidentfrom 7th day and continued till the end of the study. No significant change in any of the vitalsand laboratory parameters was observed in both the groups. The effect of Ayucid capsules was found to beequal or non inferior to that of Omeprazole in subjects suffering from GERD. Thus,Ayucid Capsule is safe and effective in the management of GERD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
- 1.Subjects having history of heartburn equal to or more than 12 months and less than 5 years.
- 2.Subjects having GERD Questionnaire score equal to or more than 8.
- 3.Subjects with current episodes of moderate to severe heartburn on at least 4 occasions in the last 7 days prior to screening.
- 4.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
- 1.Subjects who are known to have gastric ulcer, duodenal ulcer, Gastric Ca etc.
- 2.Subjects who undergone abdominal surgeries.
- 3.Subjects with an anticipated need for concomitant medication with anticholinergics, promotility agents, prostaglandin analogs, sucralfate, nonsteroidal anti-inflammatory drugs (NSAIDs), or salicylates other than low-dose aspirin 4.Chronic alcoholics and Habitual Tobacco chewers.
- 5.Known cases of Severe or Chronic hepatic or renal disease.
- Known subject of any active malignancy.
- Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Known hypersensitivity to any of the ingredients used in study drug.
- Pregnant and Lactating females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of complete resolution of heartburn in two groups Day -3, Day 0, Day 7, Day 14, Day 21, Day 28
- Secondary Outcome Measures
Name Time Method 1 Assessment of other symptoms of GERD 2 Assessment of requirement of rescue medication
Trial Locations
- Locations (3)
Ayurveda Research Center Ayurved Seva Sangh Ganeshwadi Nashik
🇮🇳Nashik, MAHARASHTRA, India
KVTR Ayurvedic College Boradi
🇮🇳Dhule, MAHARASHTRA, India
PDEAs College of Ayurvedic and Research Centre, Sector 25,Pradhikaran,Nigdi,Pune
🇮🇳Pune, MAHARASHTRA, India
Ayurveda Research Center Ayurved Seva Sangh Ganeshwadi Nashik🇮🇳Nashik, MAHARASHTRA, IndiaDr Shishir PandePrincipal investigator9420830818shishir.nsk@gmail.com