| CTRI Number |
CTRI/2024/12/078218 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Jirakadya Churna And Bhunimbadi Churna On Grahani Roga With Special Reference Irritable Bowel Syndrome. |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Jirakadya Churna & Bhunimbadi Churna in the management of Grahani Roga W.S.R. IBS |
| 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 AJEET KUMAR MAURYA |
| Designation |
PG SCHOLAR |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobhit university |
| Address |
Deparment of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobhit university Adarsh institutional area Babu vijendra marg Gangoh Saharanpur U P India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9455170008 |
| Fax |
1331234500 |
| Email |
ajitmaurya4121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AJEET KUMAR MAURYA |
| Designation |
PG SCHOLAR |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobhit university |
| Address |
Deparment of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobhit university Adarsh institutional area Babu vijendra marg Gangoh Saharanpur U P India
UTTAR PRADESH
247341
India |
| Phone |
9455170008 |
| Fax |
1331234500 |
| Email |
ajitmaurya4121@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR A P SINGH |
| Designation |
Professor and HOD Dept. of Kayachikitsa |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobhit university |
| Address |
Deparment of Kayachikitsa Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobhit university Adarsh institutional area Babu vijendra marg Gangoh Saharanpur U P India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9410088322 |
| Fax |
1331234500 |
| Email |
apsingh11264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar shekhar vijendra ayurved medical college and research centre,Shobhit university,Adarsh institutional area,Babu vijendra marg,Gangoh,Saharanpur U.P. India-247341 |
|
|
Primary Sponsor
|
| Name |
Kunwar shekhar vijendra ayurved medical college and research centre Shobhit university |
| Address |
Adarsh institutional area,Babu vijendra marg, Gangoh, Saharanpur,U.P. India-247341 |
| 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 AJEET KUMAR MAURYA |
Kunwar shekhar vijendra ayurved medical college and research centre |
OPD No-1,Departmentof Kayachikitsa
Saharanpur
UTTAR PRADESH |
9455170008
1331234500
ajitmaurya4121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar shekhar vijendra ayurved medical college and research centre Shobhit university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K581||Irritable bowel syndrome with constipation. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jirakadya Churna, Reference: à¤à¥ˆà¤·à¤œà¥à¤¯ रतà¥à¤¨à¤¾à¤µà¤²à¥€ अ०- ८/१०८- ११२, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhunimbadi Churna, Reference: च०चि०अ०- १५/१३२- १३३, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -cold jaggery water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals between the age group of 18-60yrs will be selected.
2. Individuals with classical signs and symptoms of Grahani will be selected.
3. Irrespective of gender, religion, caste and profession and chronicity will be selected for study.
4. individual willing to participate and giving informed consent.
5. Patient having clinical signs and symptoms of Grahani roga & I.B.S. as per Roma III criteria i.e. |
|
| ExclusionCriteria |
| Details |
1. Individual above 60 years.
2. Individual under 18 years.
3. Individuals suffering from any other type of systemic disorder uncontrolled DM and HTN, cardiac diseases, psychological, renal dysfunction will be excluded.
4. Individuals present with Upadrava of Grahani like Gudabhransa, Gudapaka, Gudashotha will be excluded.
5. Individual present with gastritis because the medicine contents can cause hyper acidity.
6. Individuals with evidence of malignancy.
7. Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms of Grahani Roga |
5 to 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement will be assessed on the basis of relief found in Irritable bowel syndrome |
45 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| 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
|
To study the efficacy of Jirakadya Churna and Bhunimbadi Churna in the management of Grahani Roga . This study is a single center, open labelled, randomized, interventional comparing the safety and efficacy of Jirakadya Churna 3gm twice a day and Bhunimbadi Churna 3gm twice a day for 45 days in 60 patients with Grahani Roga that will be conducted |