| CTRI Number |
CTRI/2025/03/081775 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO COMPARE THE EFFICACY OF LONG PEPPER LADDU MODAKA AS A DIET WITH SHANKHA VATI IN ACIDITY |
|
Scientific Title of Study
|
RANDOMIZED OPEN LABELLED CLINICAL STUDY TO COMPARE THE EFFICACY OF PIPPALI MODAKA AS PATHYA WITH SHANKHA VATI IN THE MANAGEMENT OF AMLAPITTA WITH SPECIAL REFERENCE TO HYPERACIDITY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAJITHA K |
| Designation |
PRINCIPAL, PROFESSOR ,HOD |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH , BANGLORE |
| Address |
Department of Swasthavritta,Room No 7,Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road,Udayapura P.O, Bangalore-560082.INDIA
Bangalore
KARNATAKA
560082
India |
| Phone |
7760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAJITHA K |
| Designation |
PRINCIPAL, PROFESSOR ,HOD |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH , BANGLORE |
| Address |
Department of Swasthavritta,Room No 7, Sri Sri College of Ayurvedic Science and Research Hospital,Kanakapura Road, Udayapura P.O,Bangalore-560082.INDIA
KARNATAKA
560082
India |
| Phone |
7760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAJITHA K |
| Designation |
PRINCIPAL, PROFESSOR ,HOD |
| Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH , BANGLORE |
| Address |
Department of Swasthavritta, Room No 7 , Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082
KARNATAKA
560082
India |
| Phone |
7760987722 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL,KANAKAPURA ROAD,560082. |
|
|
Primary Sponsor
|
| Name |
DR K SANGEETHA PATIL |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,BANGLORE.560082 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| MYSELF |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH , BANGLORE |
DEPARTMENT OF SWASTHAVRITTA,ROOM NO 7,SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL,KANAKAPURA ROAD,UDAYAPURA P.O,BANGLORE- 560082 KARNATAKA.
Bangalore
KARNATAKA |
9741589377
sanjukotnekal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PIPPALI MODAKA , Reference: HARITA SAMHITA, Route: Oral, Dosage Form: Modaka , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHANKHA VATI , Reference: BHARATHA BHIASHAJYA RATNAKAR , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects fulfilling the diagnostic criteria of Amlapitta( hyperacidity ) will be randomly selected.
2) Subjects who are willing to sign the consent and participate in the study. |
|
| ExclusionCriteria |
| Details |
1)Subjects with systematic disorder like DM,
2)Subjects diagnosed with gastric ulcer ,duodenal ulcer, gall bladder ,liver disorders.
3) Subjects with hiatus hernia
4) Subjects habituated to intake of drug ,alcohol and tobacco inducing Amlapitta
5) Subjects who had underwent surgical intervention related to gastrointestinal disorders
6) pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant decrease in the symptoms of amlapitta |
1st Assessment – 0th day
2nd Assessment – 15th day
Follow up – 22nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| generation of in depth analyzed data on different aspect of disease and its treatment. |
1st Assessment – 0th day
2nd Assessment – 15th day
Follow up – 22nd day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Amlapitta is a life style related disease prevalent all over the world. Amlapitta can be corelated with the Hyperacidity, and is one of the most common disease seen in today’s modern era with the prevalence ranging from 7.6 to 30%. Nowadays there is a drastic change in life style of mankind in all aspects due to modernization and industrialization making Amlapitta (Hyperacidity) an obstinate disorder escalating in its prevalence The main Nidanas of Amlapiita are Adhyashana, Ajeerna, Virudha Ahara Sevana due to which there is vitiation of Pitta Dosha leading to Agnimandhya which inturn causes Amlapitta. Ayurveda mainly emphasizes on prevention of disease by following Ahara, Nidra, Brahmacharya, Dinacharya ,Rutucharya etc. Ahara is one among the Trayopasthambha, which mainly concentrates on Pathya Apathya. Pathya is the one which is wholesome to Mana and do not have adverse effect, which have great influence in modifying the illness Pippali Modaka is a Pathya mentioned in the context of Amlapitta, which has three ingredients i.e Khanda Sarkara , Haritaki Churna and Pippali Churna which are cost effective and readily available Hence this study aims to evaluate the efficacy of Pippali Modaka as Pathya in Amlapitta. |