| CTRI Number |
CTRI/2025/02/080340 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between two different drug (Ghee with saindhava) administration time in Vibandha(Constipation) |
|
Scientific Title of Study
|
A conceptual and applied study of Bhaishjaya Kaala w.s.r. to Purishkathinya |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Inkal B Prajapati |
| Designation |
P.G.Scholar |
| Affiliation |
|
| Address |
OPD No 22, Department of Samhita, Siddhanta and Sanskrit, Government Ayurved College and Hospital, Dhanvantari Marga, Panigate, Vadodara, 390019, Gujarat, India
Vadodara
GUJARAT
390019
India |
| Phone |
6352804828 |
| Fax |
|
| Email |
inkalbprajapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachana Gandhi |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
OPD No 5 Department of Kayachikitsa Government Ayurved College and Hospital, Dhanvantari Marga, Panigate, Vadodara, 390019, Gujarat, India
Vadodara
GUJARAT
390019
India |
| Phone |
9428585841 |
| Fax |
|
| Email |
rachanagandhi41@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Mahesh Chand Gupta |
| Designation |
Professor & HOD |
| Affiliation |
|
| Address |
OPD No 22 Upgraded Department of Samhita, Siddhanta and Sanskrit Government Ayurved College and Hospital, Dhanvantari Marga, Panigate, Vadodara, 390019, Gujarat, India
Vadodara
GUJARAT
390019
India |
| Phone |
7976228480 |
| Fax |
|
| Email |
mcgupta.76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital, Vadodara, Gujarat, India, Pincode 390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College and Hospital, Vadodara |
| Address |
Government Ayurved College and Hospital, Dhanvantari Marga, Panigate, Vadodara, 390019, Gujarat, India |
| 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 |
| Dr Inkal B Prajapati |
OPD No 22 Department of Samhita Siddhanta and Sanskrit Government Ayurved College and Hospital |
OPD No 22 Upgraded Department of Samhita Siddhanta and Sanskrit Government Ayurved College and Hospital,Dhanvantari Marga, Panigate, Vadodara, 390019, Gujarat, India
Vadodara
GUJARAT |
63528 04828
inkalbprajapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurved College and Hospital, Vadodara |
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: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Go-ghrita and Saindhava Lavana, Reference: Charaka Samhita Chikitsa Sthana 15/204, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -500 mg of Saindhava Lavana mixed with 30 ml of Go-ghrita | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Go-ghrita and Saindhava Lavana, Reference: Charaka Samhita Chikitsa Sthana 15/204, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -500 mg of Saindhava Lavana mixed with 30 ml of Go-ghrita |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms Purishkathinya and Krucchatapurvakamalatyaga. |
|
| ExclusionCriteria |
| Details |
Patients having major systemic diseases like Cardiac disease, Chronic Kidney
Disease, Hypertension.
Pregnant women and Lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of how administering medicine at different times impacts stool consistency and frequency. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the strengthening or balancing of Agni by medicine at specific times, & its subsequent effect on the digestive process. |
14 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A randomized open labelled parallel group clinical trial will be conducted involving 30 patients diagnosed with Purishkathinya. Participants will be randomly assigned into two group. Group A will be given medicine in Madhyabhaktakaala and Group B will be given medicine in Pragbhaktakaala. Both 2 Refer to National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017 groups will go with treatment period of 7 days, with follow up after 7 days after completion of treatment. The primary outcomes will be measured through assessment criteria and symptomatic relief. |