| CTRI Number |
CTRI/2025/01/079773 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To the efficacy of Shivpalapindi Avleha and Avipattikara Churna in the patient of Amlapitta(Hyperacidity) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical study to evaluate the efficacy of Shivpalapindi Avleha and Avipattikara Churna in the management of Amlapitta |
| 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 Sawan Kumar |
| Designation |
P.G. Scholar |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 79 PG Department of Kayachikitsa
Institute For Ayurved Studies And Research, Umri Road, Sector 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
08168870817 |
| Fax |
|
| Email |
sawan1777kumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Kumari |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 79 PG Department of Kayachikitsa
Institute For Ayurved Studies And Research, Umri Road, Sector 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Kumari |
| Designation |
Professor, Department of Kayachikitsa |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
Room no 79 PG Department of Kayachikitsa
Institute For Ayurved Studies And Research, Umri Road, Sector 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9671368058 |
| Fax |
|
| Email |
mehranilam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra pin 136118, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra |
| Address |
Institute For Ayurved Studies And Research, Umri road, sector 8, Kurukshetra pin 136118 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sawan Kumar |
Institute for Ayurved Studies and Research |
Room no 56, PG Department of Kayachikitsa, Umri road sector 8 Kurukshetra, pin 136118
Kurukshetra
HARYANA |
08168870817
sawan1777kumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Krishna Ayush University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shivapalapindi Avleha , Reference: Bhav Prakash Madhya Khand Chapter 10, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avipattikara Churna, Reference: Bhaishajya Ratnavali 56/25-29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Luke warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Willing for clinical trials and ready to give written consent.
2 Patients with cardinal symptoms of Amlapitta viz. Avipaka, Klma, Utklesha, Tikta Amla Udgara, Guruta, Hrit-Kantha Daha, Aruchi.
3 Patient willing to take ayurveda treatment.
|
|
| ExclusionCriteria |
| Details |
1 Bahudosha Avestha that required Shodhana Chikitsa.
2 Patient already suffering with CA stomach.
3 Already diagnosed cases of peptic ulcer disease.
4 H/O hematemesis, melena and other systemic disorder that interfere with clinical trial
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients showing improvement in the score of assessment criteria of Amlapitta. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements in emotional well-being, physical and mental growth, strength, cognitive performance, and overall quality of life. |
7th day 14th day 21th day 28th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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
|
According to Ayurveda, the main cause of every disease is Agnimandhya. Due to erratic lifestyles, the food habits of people are disturbed(virudahahara). Due to these food habits for long period of time, the tridoshas are vitiated which leads to Agnimandhya. In these condition people continues have the incompatible dietetics (virudahahara) and lifestyles due to which the Agni become more manda and pitta (pachaka pitta) dosha which normally helps in the digestion of the food become vitiated. As consequences, drava and amla guna of pitta are increased which cause vidhagdta in the pitta dosha and eaten food. This is referred as Amlapitta in ayurveda. |