Management of Amlapitta by Dashanga Ghanavati

Phase 3

Completed

• Conditions: Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM,

• Registration Number: CTRI/2022/01/039302
• Lead Sponsor: DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA ITRA GUJARAT AYURVEDA UNIVERSITY JAMNAGAR

Brief Summary

It is a randomized control clinical trial to assess efficacy of *Dashanga Ghanavati* in the management of *Urdhvaga Amlapitta*. Here known or newly diagnosed case of *Amlapitta* having three or more symptoms of *Urdhvaga Amlapitta*, age between 18-60 year and willing to participate in present trial will be registered irrespective of their caste, gender, occupation or religion. Patient having age below 18 years and above 60 years of age, having Peptic ulcer, Duodenal ulcer, Pancreatic disease, hepatic disease, Inflammatory bowel disease, Malignancy of G.I.T or not willing to participate will be excluded from present study. Recruit patients will be investigated (CBC, Urine, Stool) to rule out after common pathological condition. patient will be randomized in the base of computerised generated chart. Group A patients will be given *Dashanga Ghanavati* 4 tab (500 mg each) before breakfast, lunch and dinner thrice/ day with honey for 30 days. Group B patients will receive placebo capsules (roasted Sooji) before breakfast, lunch and dinner with Luke warm water. Duration for medication will be 30 days for both the group. Patient will be assessed on day 0, day 15 and day 30 to assess intensity and improvement in symptoms after completion of trial, patient follow up will be done for one month at the interval of 15 days. During the period of follow up no medication will be given to the patient. If recurrence of symptoms is found routine OPD medicine will be given to the patient. Detail history along with demographic data, patient’s symptom improvement assessment will be based on scoring pattern that will be adopted from work of Sandip R. et al. improvement in quality of life of the patient will be assessed on the bais of SF- 36. Obtained data will be analysed with Wilcoxon sign rank test and Mann- whitney test.

At the end of the therapy In *Dashanga Ghanavati* group 95.65% improvement was foundin*Utklesha*followed by *Amla Udgara* (91.84%), *Chhardi* (90.48%), *Aruchi*(88.57%), *Avipaka* and *Udara Gaurava* each (87.01%), *Shiro Ruja* (86.85%), *Kukshi Daha* (79.49%) and *Hradaya Daha* (78.57%) that remained statistically highly significant (p<0.001)

100% improvement was found in *Tikta Udgara, Kantha Daha, Tikta Amla Udgara, Kara- Pada daha*and*Ushnata*in eachfollowed by *Klama*(90.48%). In this symptoms calculation could not possible due to insufficient patients.

while In placebo group 100% improvement was found in *Tikta Udgara*and*Kara- Pada daha* each followed by *Chhardi*(91.3%), *Amla Udgara* (79.07%), *Utklesha* (76.47%), *Kukshi Daha* (72.22%), *Hradaya Daha* (59.09%), *Klama* (58.82%), *Avipaka*and *Udara Gaurava*each (53.62%) and *Aruchi* (45.45%) that remained statistically highly significant (p<0.001). *Shiro Ruja* (66.67%) remained statistically very significant (p<0.01). *Kantha Daha* (92.31%) and *Ushnata* (75%) remained statistically insignificant (p>0.05)

100% improvement was found in *Tikta Udgara*and*Kara- Pada daha* each followed by*Tikta Amla Udgara* (80%)

While in comparing both the group *Avipaka, Udara gaurava* and *Aruchi* remained statistically highly significant (p<0.001). *Hradaya Daha* remained statistically very significant (p<0.01). *Shiro Ruja* and *Amla Udgara*remained statistically significant (p<0.05). *Kukshi Daha* and *Chhardi* remained statistically insignificant (p>0.05)

Study has been concluded that *Dashanga Ghanavati*is effective in the management of *Urdhvaga* *Amlapitta* improve the quality of life, without any side effect.

Hence null hypothesis (H0) is rejected and alternative hypothesis (H1) is accepted.

No adverse drug reaction or undesirable effects were observed in any of patients during the clinical trials and follow up.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Study Completion: 2023-08-28
• Last Update Posted: 2023-12-10

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Known or newly disease case of Amlapitta along with three or more symptoms of Urdhvaga Amlapitta like Avipaka, Klama, Utklesha, Tiktamla Udgara, Anga Gaurava, Hrit-Kukshi-Kanth Daha, Aruchi, Shirah shool, Tiktamla Vami Bhukte- Vidagdhe-bhukte-Abhukte.
• Willing to participate in the study / Ready to abide study protocol.

Exclusion Criteria

• Patients below 18 year and above 60 years of age.
• Patient suffering from gastrointestinal disorders other than Urdhvaga Amlapitta like Peptic ulcer, Duodenal ulcer, Pancreatic disease, hepatic disease, Inflammatory bowel disease, Malignancy of G.I.T Any systemic disease like Diabetes mellitus, uncontrolled hypertension, patients taking NSAIDs. Patients not willing to participate / Not ready to abide study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in symptoms of Urdhvaga Amlapitta	4 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life of the patient	1 MONTH

Trial Locations

Locations (1)

ITRA HOSPITAL; 🇮🇳 Jamnagar, GUJARAT, India

ITRA HOSPITAL

🇮🇳Jamnagar, GUJARAT, India

BHARATI SOLANKI

Principal investigator

08780876327

solankibharti163@gmail.com