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CTRI Number  CTRI/2022/01/039302 [Registered on: 10/01/2022] Trial Registered Prospectively
Last Modified On: 12/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Management of Amlapitta by Dashanga Ghanavati 
Scientific Title of Study   Efficacy of Dashanga Ghanavati in the management of Urdhvaga Amlapitta – An open label single blind randomized control clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BHARATI SOLANKI 
Designation  MD Ayurved scholar 
Affiliation  ITRA JAMNAGAR 
Address  ROOM NO 515,DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIJNANA, INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA, GUJARAT AYURVED UNIVERSITY,JAMNAGAR

Jamnagar
GUJARAT
361008
India 
Phone  8780876327  
Fax    
Email  solankibharti163@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR DARSHNA PANDYA 
Designation  ASSISTANT PROFESSOR OF ROGA NIDANA EVUM VIKRITI VIGYANA  
Affiliation  ITRA JAMNAGAR 
Address  ROOM NO- 515, DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIJNANA,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA, GUJARAT AYURVEDA UNIVERSITY,JAMNAGAR

Jamnagar
GUJARAT
361008
India 
Phone  9099011095  
Fax  02882676856  
Email  darshnapandya73@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR DARSHNA PANDYA 
Designation  ASSISTANT PROFESSOR OF ROGA NIDANA EVUM VIKRITI VIGYANA  
Affiliation  ITRA JAMNAGAR 
Address  ROOM NO- 515, DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIJNANA,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA, GUJARAT AYURVEDA UNIVERSITY,JAMNAGAR

Jamnagar
GUJARAT
361008
India 
Phone  9099011095  
Fax  02882676856  
Email  darshnapandya73@gmail.com  
 
Source of Monetary or Material Support  
ITRA HOSPITAL JAMNAGAR 
 
Primary Sponsor  
Name  DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA ITRA GUJARAT AYURVEDA UNIVERSITY JAMNAGAR 
Address  OPD NO 16,DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIJNANA, INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA, GUJARAT AYURVEDA UNIVERSITY, OPPOSITE CITY, B DICISION POLICE STATION, PN MARG, JAMNAGAR-361008 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
BHARATI SOLANKI  ITRA HOSPITAL  DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIJNANA, INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA, GUJARAT AYURVEDA UNIVERSITY,OPP CITY B DIVISION POLICE STATION, PN MARG, JAMNAGAR 361008
Jamnagar
GUJARAT 
08780876327

solankibharti163@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ITRA JAMNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K210||Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: DASHANGA GHANAVATI, Reference: CHAKRADATTA AMLAPITTACHIKITSA 52/11, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -MADHU), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in symptoms of Urdhvaga Amlapitta  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life of the patient   1 MONTH 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "57"
Final Enrollment numbers achieved (India)="57" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/05/2022 
Date of Study Completion (India) 28/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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 foundinUtklesha 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 each followed 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.

 
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