| CTRI Number |
CTRI/2025/02/080979 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Marichadi Choorna Orally In Comparision With Dadimashtaka Choorna Orally 6 Gram Twice Daily In Irritable Bowel Syndrome In Adults Of Age Group 20-60 Years For A Period Of 30 Days |
|
Scientific Title of Study
|
To Study The Efficacy Of Marichadi Choorna in Comparision with Dadimashtaka Choorna In Grahani Roga: A Controlled Randomized Clinical Study |
| 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 Sameeksha N Ariga |
| Designation |
Post Graduate Scholar Kayachikitsa Department |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital, Bengaluru |
| Address |
Dept of Kayachikitsa OPD No. 1,2,3,18,27
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya, Kumbalagodu post, Bengaluru-560074, Karnataka India
Bangalore
KARNATAKA
560074
India |
| Phone |
7338273499 |
| Fax |
|
| Email |
arigasameeksha3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Bhat |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital, Bengaluru |
| Address |
Dept of Kayachikitsa OPD No.3
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya, Kumbalagodu post, Bengaluru-560074, Karnataka India
Bangalore
KARNATAKA
560074
India |
| Phone |
9986451162 |
| Fax |
|
| Email |
dr.priyabhat23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameeksha N Ariga |
| Designation |
Post Graduate Scholar kayachikitsa Department |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital, Bengaluru |
| Address |
Dept of Kayachikitsa OPD No. 1,2,3,18,27
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya, Kumbalagodu post, Bengaluru-560074, Karnataka India
Bangalore
KARNATAKA
560074
India |
| Phone |
7338273499 |
| Fax |
|
| Email |
arigasameeksha3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept Of Kayachikitsa OPD No 1,2,3,18,27
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital, SH 17 Bengaluru Anchepalya, Kumbalagodu post, Bangalore - 560074, Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Sameeksha N Ariga |
| Address |
Dept Of Kayachikitsa OPD No 1,2,3,18,27
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital, SH 17 Bengaluru Anchepalya, Kumbalagodu post, Bangalore - 560074, Karnataka
India |
| 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 Sameeksha N Ariga |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru |
Dept of Kayachikitsa OPD No. 1,2,3,18,27
Shri Dharmasthala Manjunatheshwara Institute Of Ayurveda and Hospital Anchepalya, Kumbalagodu post, Bengaluru-560074, Karnataka India
Bangalore
KARNATAKA |
07338273499
arigasameeksha3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Marichadi choorna , Reference: CHAKRADATTA GRAHANIROGADHIKARA 4th CHAPTER 29 SHLOKA (4/29), Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: 100ml Takra with 3 pinch Guda ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dadimastaka choorna , Reference: CHAKRADATTA GRAHANIROGADHIKARA 4th CHAPTER 35 to 36 SHLOKA (4/35-36), Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: 100ml Takra ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with classical lakshana of grahani
1 Muhur baddha Muhur drava mala pravritthi (Altered bowel habit)
2 Udara shoola (Abdominal pain)
3 Tikta amlodgara (Dyspepsia)
4 Adhmana (Abdominal distention)
5 Arochaka (Anorexia)
6 Bala kshaya (loss of strength)
Rome’s 4 criteria for diagnosis of IBS
Recurrent abdominal pain on average at least 1 day per week in the last 3 months associated with 02 or more of the following criteria:
1 Related to defecation
2 Associated with a change in frequency of stool
3 Associated with a change in form(appearance) of stool
Subjects with either sex irrespective of religion within the age group of 20-60years
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from systemic disorders like uncontrolled diabetes mellitus uncontrolled hypertension
Subjects suffering from infective diarrhoea, Lactose intolerance, Other GI disorders except dyspepsia.
Subjects who are pregnant, lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Marichadi choorna with Dadimashtaka choorna based on improvements in IBS severity score and lakshanas in patients diagnosed with Grahani |
0th day(Baseline), 15th day, 30th day and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Marichadi choorna with Dadimashtaka choorna in improvements of signs and symptoms by assessing the IBS related quality of life questionnaires in patients diagnosed with Grahani roga. |
0th Day(Baseline), 15th day, 30th day and 45th day |
|
|
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)
|
05/03/2025 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Management of Grahani roga in adults of age group 20-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Grahani roga will be recruited and divided into two groups. Group A ( Trial drug/ Intervention group). It includes 15 subjects qualifying inclusion criteria of the current study will be administered Marichadi choorna internally in the dose of 6 grams twice daily in between meals with takra and guda as anupana for 30 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. Group B (Control drug/ Comparator group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Dadimashtaka choorna internally in the dose of 6 grams twice daily in between meals with takra for 30 days starting from day-01 of trial, assessment of the patient during trial on 0th day(baseline), 15th day, 30th day and after trial on 45th day. The primary outcome measure will be significant improvements in IBS severity score and lakshanas in patients diagnosed with Grahani roga after 30 days. The secondary outcome measure will be improvement noticed in signs and symptoms by assessing the IBS related quality of life questionnaires in patients diagnosed with Grahani roga after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment. |