| CTRI Number |
CTRI/2025/03/081924 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study conducted to see the effect of Kayam purandaradi churna and Mustaadi churna in the management of grahani with special reference to Irritable bowel syndrome |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the effect of Kayam Purandaradi Churna And Mustaadi Churna in the Management of Grahani with special reference to Irritable Bowel Syndrome |
| 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 TABASSUM I MULLA |
| Designation |
POSTGRADUATE |
| Affiliation |
Bvvs ayurvedic Medical College And Hospital Bagalkot 587101 |
| Address |
Department of PG Studies in Kayachikitsa BVVS AYURVEDIC MEDICAL COLLEGE AND HOSPITAL BVVS Campus BAGALKOT 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
7812902354 |
| Fax |
|
| Email |
tabbu11mulla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S S Kalyani |
| Designation |
Professor |
| Affiliation |
BVVS Ayurveda Medical College And Hospital Bagalkot |
| Address |
Department of PG studies in Kayachikitsa BVVS Ayurveda Medical College And Hospital BVVS Campus Bagalkot 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
9591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S S Kalyani |
| Designation |
Professor |
| Affiliation |
BVVS Ayurveda Medical College And Hospital Bagalkot |
| Address |
Department of PG studies in Kayachikitsa BVVS Ayurveda Medical College And Hospital BVVS Campus Bagalkot 587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
9591273858 |
| Fax |
|
| Email |
drleelakalyani@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurvedic Medical College and Hospital Bagalkot Karnataka 587101 |
|
|
Primary Sponsor
|
| Name |
BVVS Ayurveda medical college and hospital bagalakot |
| Address |
Department of PG Studies in Kayachikitsa BVVS Ayurvedic Medical College and Hospital BVVS Campus Bagalkot 587101 |
| 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 Tabassum I Mulla |
BVVS Ayurved Medical College and Hospital |
Department of PG Studies in Kayachikitsa, BVVS Ayurveda medical college and hospital,
BVVS Campus Bagalkot
Bagalkot
KARNATAKA |
7812902354
tabbu11mulla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECBVVSAYURVEDMEDICALCOLLEGE |
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: Mustaadi churna , Reference: Bhavaprakasha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kayampurandaradi churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient fulfilling the symptoms of ROME 4 Criteria of IBS
2. Patients between the age group of 18 to 60 years |
|
| ExclusionCriteria |
| Details |
1.Diagnosed cases of ca colon,Ulcerative colitis, crohns diasese
2.pregnacy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the effect of Mustaadi churna and Kayam purandaradi churna in the management of grahani with special reference to Irritable Bowel Syndrome |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Aims and objectives of the study
1. To compare the effect of Kayampurandaradi churna and Mustaadi churna in the management of Grahani with special reference of Irritable Bowel Syndrome
2. To evaluate the effect of kayam purnadaradi churna in the management of Grahani with special reference to Irritable bowel syndrome
3. To evaluate the effect of Mustaadi churna in the management of Grahani with special reference to Irritable Bowel Syndrome |
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 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
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
|
Grahani and Agni are having Ashraya - Ashrayi Sambhndha. Grahani is described as Agni Adhishthana. Ayu, Varna, Bala, Swasthya, Utsaha, Prabha, Oja, Tejo Agni and Prana all of these are depending on Agni. Grahani is a disease of Annavaha Srotas caused by Aharaja, Viharaja and Manasika Nidanas like Abhojana, Ajeerna Bhojana, Ati Bhojana , Vishamaashana, Asatmya Bhojana, Guru Sheeta Bhojana ,Vega Sandharana , Chinta, Shoka and Bhaya. Due to these Nidanas Agni gets vitiated and causes the Symptoms of Grahani Grahani is characterized by Vibaddha Va Drava Mala Pravruti, Trushna, Arochaka, Vairasya, Praseka, Tamaka, Shuna Padakara, Asthi Parvaruk, Chardi, Jvara and Tikta Amla Udgaar. Based on similar signs and symptoms of Grahani can be Co- related with Irritable Bowel Syndrome. Irritable Bowel Syndrome is a functional disorder of Gastro-Intestinal Tract. It is one of the most common conditions encountered in clinical practice. It has a significant effect on health and quality of life. It is generally believed that most patient develop symptoms in response to psychosocial factors, altered GI motility and altered visceral sensation. Irritable bowel syndrome is characterized by altered bowel habits, abdominal pain, gas and flatulence. Prevalence rate of Irritable bowel syndrome in India is 0.4% to 4.2%, Women are diagnosed with two to three times as often as men. In modern medicine treatment modalities include administration of anti spasmodic, stool bulking agents, anti diarrheal agents, anti depressants and anti flatulence therapy. These are helpful in the symptomatic management of the disease, Most patients have a relapsing and remitting course often followed by stressful life events. In Ayurvedic classics treatment modalities for Agni Dushti include Langhana, Deepana, Paachana, and Sangrahana. As Grahani caused due to Agni Dushti , So the main line of treatment is to correct the Agni Dushti. Mustaadi Churna mentioned in BhavaPrakasha contains Ingredients like Musta, Ativisha, Bilwa and Kutaja having Katu Tikta Rasa, Laghu Guna, Ushna Veerya, Grahi , Deepana and Paachana Propertis helpful in the management of Grahani by correcting Agni Dushti. Kayam Purandaradi Churna mentioned in Sahasrayoga contains Ingrdients like Hingu, Indra Yava , Ativisha, Vacha, Haritaki, Sauvarchala Lavana these drugs are having Laghu guna , Ushna Veerya, Deepana , Paachana and Grahi properties which are helpful in the management of Grahani by correcting the Agni Dushti. Hence present study will be aimed to evaluate and compare the effect of Kayam Purandaradi Churna and Mustaadi Churna in Grahani with special reference to Irritable Bowel Syndrome. |