| CTRI Number |
CTRI/2025/06/089356 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Probiotic
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparosion between Chitrakaadi Vati and Panchkolsidhha Peya in malabsorption. |
|
Scientific Title of Study
|
A Comparative Study of Chitrakaadi Vati and Panchkolsidhha Peya in Grahani |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSwati Sharma |
| Designation |
Ph.D. Scholar |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
D Block, 4th floor, room no. 401, Faculty of Indian Medical System, SGT University, Gurugram.
D Block, 4th floor, room no. 401, Faculty of Indian Medical System, SGT University, Gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
07428084702 |
| Fax |
|
| Email |
dr.swati158@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta Gupta |
| Designation |
Professor, Rog Nidan |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
D Block, 4th floor, room no. 401, Faculty of Indian Medical System, SGT University, Gurugram.
D Block, 4th floor, room no. 401, Faculty of Indian Medical System, SGT University, Gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
8178049086 |
| Fax |
|
| Email |
sangeeta.fims@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
DrSwati Sharma |
| Designation |
Ph.D. scholar & Assistant Professor, Rog Nidan |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
D Block, 4th floor, room no. 401, Faculty of Indian Medical System, SGT University, Gurugram.
D Block, 4th floor, room no. 401, Faculty of Indian Medical System, SGT University, Gurugram.
Gurgaon
HARYANA
122505
India |
| Phone |
08168175876 |
| Fax |
|
| Email |
swati.sharma_fims@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
| SGT Ayurvedic Hospital, Kaliyawas village, Gurugram, Haryana. Pin- 122505 |
|
|
Primary Sponsor
|
| Name |
SGT University Gurugram Haryana |
| Address |
D Block 4th floor room no 401 Faculty of Indian Medical System SGT University Gurugram pin 122505 |
| Type of Sponsor |
Private 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 |
| DrSwati Sharma |
SGT University, Gurugram, Haryana |
D Block, 4th floor, room no. 401, Faculty of Indian Medical System, SGT University, Gurugram. Pin 122505
Gurgaon
HARYANA |
08168175876
dr.swati158@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: GRAHANIDOSHAH, (2) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Gutika, Reference: Charak Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: -Before starting this treatment Erand Bhrishta Haritaki will be given for Koshtha Shuddhi for 5 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchkol Peya, Reference: Ashtanghridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -Peya), Additional Information: -Before starting this treatment Erand Bhrishta Haritaki will be given for Koshtha Shuddhi for 5 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the mentioned age group who have visible symptoms of Grahani will be taken for study. |
|
| ExclusionCriteria |
| Details |
Pregnancy, Lactation or any other serious systemic ailment, other gastrointestinal diseases Atisara, Gulma, Pravahika. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Panchkol Peya in the management of Grahani Roga in comparision to Chitrakadi Gutika, already proven drug. |
After 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the reduction in symptoms like bloating, indigestion, & irregular bowel movements
To study the reduction in Ama formation in individuals with Grahani Roga
To assess the improvement in Agni (digestive fire)
|
After 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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 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
|
Grahani Roga is a disease that
affects the Annavaha and Purishavaha Srotasa and is closely
related to the imbalance of Agni and the formation of Ama.Ayurveda emphasizes the role of Agni in
maintaining overall health. Disruptions in Agni are believed to be central to
the development of Grahani Rog. Both drugs’ ingredients are known to stimulate
digestive fire and improve the function of the gastrointestinal tract. By
focusing on how Panchkol Peya and Chitrakaadi Gutika works at a physiological
level, the research can contribute to a better understanding of its role in
restoring Agni and improving digestive health.§ One trial group will be given Erand Bhrishta Haritaki
for Koshtha Shudhhi continuously for 5 days followed by administration of
Panchkol Peya daily for 4 weeks during lunch and another control group will be similarly
given EBH for Koshtha Shudhhi followed by Chitrakadi Gutika for the same
duration and results will be compared. |