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
|
|
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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | (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. |