| CTRI Number |
CTRI/2026/01/101461 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A human trial for two drugs which are YAMANIPANCHAKA VATI and DEVADARVYADI VATI for the treatment of Grahni Roga w.s.r IBS in children |
|
Scientific Title of Study
|
A RANDOMISED CONTROL TRIAL ON YAMANIPANCHAKA VATI AND DEVADARVYADI VATI IN THE MANAGEMENT OF GRAHNI ROGA W.S.R. IBS IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parul Kaushik |
| Designation |
Ph.D Scholar |
| Affiliation |
Desh Bhagat Ayurvedic College |
| Address |
Desh Bhagat Ayurvedic College Village Sounti Amloh Distt Fategarh Punjab
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
8750021904 |
| Fax |
|
| Email |
kaushikparul71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Hemraj |
| Designation |
Principal & HOD Kayachikitsa |
| Affiliation |
Desh Bhagat Ayurvedic College |
| Address |
Desh Bhagat Ayurvedic College & Hospital, Village Sounti, Amloh
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
9418004077 |
| Fax |
|
| Email |
hemraj22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Hemraj |
| Designation |
Principal & HOD Kayachikitsa |
| Affiliation |
Desh Bhagat Ayurvedic College |
| Address |
Desh Bhagat Ayurvedic College & Hospital, Village Sounti, Amloh
Fatehgarh Sahib
PUNJAB
147203
India |
| Phone |
9418004077 |
| Fax |
|
| Email |
hemraj22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gaur Brahmin Ayurvedic College & Hospital, VPO Brahmanwas, Rohtak, Haryana, India
Pin- 124001 |
|
|
Primary Sponsor
|
| Name |
Parul Kaushik |
| Address |
Desh Bhagat Ayurvedic College Village Sounti Amloh Distt Fatehgarh Punjab India
Pin code 147203 |
| 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 |
| Dr Parul Kaushik |
OPD No.5, Balroga OPD |
Gaur Brahmin Ayurvedic College & Hospital, Brahmanwas, Rohtak
Rohtak
HARYANA |
8750021904
kaushikparul71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Devdarvyadi Vati, Reference: Charaka Samhita, Chikitsa Sthana, 15th chapter, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yamanipanchaka Vati, Reference: Bhaishajya Ratnawali Chapter 71, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject of age group 5 year to 16 year.
2. Subject suffering from symptoms of Grahani (mild to moderate IBS)
|
|
| ExclusionCriteria |
| Details |
1. Subject Below age 5 year and Above 16 year of age.
2. Subjects with severe diarrhea and dehydration.
3. Subject with complications; Chronic disease.
4. Subject with PEM/ SAM/MAM.
5. Subject has history of any disease- DM / CHD etc.
6. Mentally retarded subjects |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
From this clinical study, it is expected to have a better drug option out of these two that will be available
for Grahni Roga in children and will be most effective and have no side-effects. |
The follow ups or outcomes are assessed at 0th day(baseline), 14th day, 28th day, 42nd day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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 Yet Recruiting |
| 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
|
This study is proposed for Ph.D. research/ thesis work. Adolescence is a pivotal phase of growth and development, during which gastrointestinal problems, such as Grahani Roga, may arise. The primary causes of Grahani Roga in youngsters are the disturbance of Agni, either directly from exposure to various etiological factors or because to pre-existing Mandagni, exacerbated by inappropriate food selections. Symptoms of IBS have similarities with the symptoms of Grahani Dosha like, alternation in bowel habits (Muhur-baddha, Muhur-drava), stools mixed with mucus (Shleshma mal Pravritti) etc. The aspect of malabsorption and mal functioning of digestive fire stretched my interest to study on the topic effective management of grahani with special reference to IBS. Children are more delicate, having Alpa-Bala, Alpa-Satva and Aniyata-Agni, they are easily affected by favourable and unfavourable conditions like Mithya Ahara Vihara. Fast food and junk food consumption in the modern world, along with ongoing stress, further disrupts the digestive system and leads to a number of gastrointestinal tract-related illnesses, of which Grahani Roga is one of the most common. |