| CTRI Number |
CTRI/2025/01/079422 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment of IBS(Grahani) using ayurvedic medicine.The treatment consist of Nagaradya churna orally with anupan as a madhu. |
|
Scientific Title of Study
|
TO VALIDATE THE PRINCIPLE OF SADEEPAN CHIKITSA WITH THE HELP OF NAGARADYA CHURNA IN GRAHANI ROGA |
| 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 ISHWARI SACHAN |
| Designation |
MD SCHOLAR PG DEPARTMENT OF SAMHITA SIDDHANTA DEPARTMENT |
| Affiliation |
PANDIT KHUSHILAL SHARMA GOVERNMENT AUOTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE |
| Address |
ROOM NO 231 DEPARTMENT OF SAMHITA SIDDHANTA PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827291091 |
| Fax |
|
| Email |
tarasachan3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PAWAN KIRAR |
| Designation |
LECTURER OF DEPARTMENT OF SAMHITA SIDDHANTA |
| Affiliation |
PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE |
| Address |
ROOM NO 231 DEPARTMENT OF SAMHITA SIDDHANTA PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9424786559 |
| Fax |
|
| Email |
dr.pawan1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ISHWARI SACHAN |
| Designation |
MD SCHOLAR PG DEPARTMENT OF SAMHITA SIDDHANTA |
| Affiliation |
PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 231 DEPARTMENT OF SAMHITA SIDDHANTA PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827291091 |
| Fax |
|
| Email |
tarasachan3@gmail.com |
|
|
Source of Monetary or Material Support
|
| PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE BHOPAL MP |
|
|
Primary Sponsor
|
| Name |
Pt. KHUSHILAL SHARMA GOVT AUTO AYURVEDA MEDICAL COLLEGE AND INSTITUTE |
| Address |
science hills behind Manit, kolar road nehru nagar |
| 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 ISHWARI SACHAN |
PANDIT KHUSHILAL SHARMA GOVERNMENT AUTONOMOUS AYURVEDA MEDICAL COLLEGE AND INSTITUTE |
ROOM NO 231 DEPARTMENT OF SAMHITA SIDDHANTA SCIENCE HILLS BEHIND MANIT KOLAR BYPASS NEHRU NAGAR
Bhopal
MADHYA PRADESH |
9244526545
tarasachan3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE Pt. KHUSHILAL SHARMA GOVT AUTO AYURVEDA COLLEGE AND INSTITUTE BHOPAL |
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: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: NAGARADYA CHURNA, Reference: CHARAK CHIKITSA STHAN 15/129 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -NIL(2) Medicine Name: LAJA POWDER, Reference: NIL, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -NIL |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.All the participants with classical symptoms of grahani roga.
2.Participants between 20 to 50 yrs of age group of either sex.
3.Participants who are willing to come under this study with consent. |
|
| ExclusionCriteria |
| Details |
1. Participants suffering from acute diarrhoea, liver disease,gastric and peptic ulcer,ulcerative colitis, crohns disease, intestinal tuberculosis, diabetes mellitus, hiv cases and colon cancer.
2. Age group below 20 and above 50 yrs. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in subjective and objective criteria assessed. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is expected at the end of study we would be able to evaluate the significant effect of Nagaradya churna in Grahani roga. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
04/02/2025 |
| 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 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
|
Many research work has been carried out on Grahani Roga (IBS) in Ayurveda and in contemporary system of medicine. it is still remain as a hazardous problem and serious complication. Nagaradya churna has agnideepan property and reduces the symptoms of Grahani. Information on the trial procedure and drug- in group A we are giving 5 gm Nagaradya churna twice a day with madhu as anupan before meal. And in group B placebo group capsules of laja powder is given. we assure that we will prepare formulation with as per S.O.P.s in the pharmacy of PTKLS. Description of the process- in present study participants who will be clinically diagnosed and confirmed cases of Grahani enlisted in inclusion criteria will be enrolled minimum 40 patients and will be divided into 2 groups. Follow up- it will be for one month duration at interval of 15 days. Side effects- we will follow closely and keep track of any unwanted effects. Results- the efficacy of the drug will be assessed on the basis of subjective criteria. |