| CTRI Number |
CTRI/2025/07/090203 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two types of Chitraka Ghrita to find the better one for treating poor digestion. |
|
Scientific Title of Study
|
A Comparative Pharmaceutico-Analytical Study of Two Different Formulations of Chitraka Ghrita and Their Clinical Evaluation w. s. r to Agnimandya |
| 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 Adithya Narayana Bhat |
| Designation |
PG Scholar |
| Affiliation |
KVG Ayurveda Medical college and hospital |
| Address |
Room No. 3, Kayachikitsa OPD, KVG Ayurveda Medical college and hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, 574239
Department of RasaShastra and Bhaishajya Kalpana,
KVG Ayurveda Medical college and hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, 574239
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
9880122227 |
| Fax |
|
| Email |
adimuliyala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purushotham K G |
| Designation |
Proffessor and HOD |
| Affiliation |
KVG Ayurveda Medical college and hospital |
| Address |
Department of RasaShastra and Bhaishajya Kalpana,
KVG Ayurveda Medical college and hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, 574239
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
7204832002 |
| Fax |
|
| Email |
drpurushothamkg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purushotham K G |
| Designation |
Proffessor and HOD |
| Affiliation |
KVG Ayurveda Medical college and hospital |
| Address |
Department of RasaShastra and Bhaishajya Kalpana,
KVG Ayurveda Medical college and hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, 574239
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
7204832002 |
| Fax |
|
| Email |
drpurushothamkg@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Ayurveda Medical college and Hospital Ambate adka sullia Dakshina Kannada Karnataka, India 574239 |
|
|
Primary Sponsor
|
| Name |
Dr. Adithya Narayana Bhat |
| Address |
KVG Ayurveda Medical college and hospital, Ambatedka, Kurunjibhag, Jattipalla, Sullia, Dakshina Kannada, 574239 |
| 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 |
| Dr Adithya Narayana Bhat |
KVG Ayurveda Medical College and Hospital |
Room No-3 , Kayachikitsa OPD,
KVG Ayurveda Medical
College and
Hospital,Ambatedka,
Kurunjibhag, Jattipalla,
Sullia, Dakshina
Kannada- 574327
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA |
9880122227
adimuliyala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurvdea Medical College Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: MANDAGNIH/ AGNISADA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitraka ghrita 1 , Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ushnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chitraka Ghrita 2 , Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: ushnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with lakshanas of Mandagni as mentioned in classics,
H/O symptoms within 3 months,
Persisting symptoms more than 3 days. |
|
| ExclusionCriteria |
| Details |
Age less than 16 years and more than 60 years,
Preganacy and Lactation,
Severe Renal/Hepatic/Cardiac disease,
Patients with psychic disorders,
Patients diagnosed with any structural disease of GIT,
Agnimandya as a symptom of other disease. |
|
|
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 |
| Improvement in Agnimandya assessed through following parameters: Abhyavahare Abhilasha, Ruchi Ahara Kale, Ahara Pramana, Ahara Jarana Kala, Jeerna Ahara Lakshana (Jarana Shakti), Utsaha, and Bala. by giving scores before and after treatment. |
Day 0 (Before treatment), Day 7 (After treatment), Day 10 (Follow-up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of clinical response between two formulations of Chitraka Ghrita in Mandagni based on Ayurvedic parameters |
Day 7 (end of drug administration), Day 10 (follow-up) |
|
|
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)
|
18/07/2025 |
| 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="0"
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
|
This is a prospective, randomized, comparative pharmaceutico-analytical and clinical study designed to evaluate two formulations of Chitraka Ghrita in the management of Agnimandya.
The first formulation uses Ghrita prepared through a classical method involving Chitraka-moola-lepita vessel as referenced in Chakradatta, while the second uses conventionally prepared Ghrita without the lepita step.
The study aims to assess whether the classical pharmaceutical method, which is more time-consuming and effort-intensive, provides superior clinical efficacy to justify its use. Both formulations will be analyzed for their physicochemical properties.
A total of 30 patients diagnosed with Mandagni will be selected and randomly divided into two groups. Clinical efficacy will be assessed using structured Ayurvedic parameters including Abhyavahare Abhilasha, Ruchi Ahara Kale, Ahara Pramana, Ahara Jarana Kala, Jeerna Ahara Lakshana (Jarana Shakti), Utsaha, and Bala, evaluated before and after intervention. |