| CTRI Number |
CTRI/2024/11/077227 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Other (Specify) [Laghu Shankaprakashalan (LSP)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of Laghushankhaprakshalana (LSP) in the management of vataj grahani roga W.S.R Irritable bowel syndrome [IBS] |
|
Scientific Title of Study
|
To evaluate the effect of Laghushankhaprakshalana (LSP) in the management of vataj grahani roga W.S.R Irritable bowel syndrome [IBS]- A comparative randomized controlled open label clinical trial |
| 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 Nikhil Sharma |
| Designation |
MD scholar |
| Affiliation |
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India |
| Address |
6th Floor Room no. 622(Seminar Hall) Department Of Swasthavritta All India Institute Of
Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
8527712731 |
| Fax |
|
| Email |
nikhisharmadelhi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Medha Kulkarni |
| Designation |
HOD |
| Affiliation |
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India |
| Address |
6th Floor Room no. 601 Department Of Swasthavritta All India Institute Of
Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9890355305 |
| Fax |
|
| Email |
Medha63@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Medha Kulkarni |
| Designation |
HOD |
| Affiliation |
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India |
| Address |
6th Floor Room no. 601 Department Of Swasthavritta All India Institute Of
Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
9890355305 |
| Fax |
|
| Email |
Medha63@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of
Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| 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 Nikhil Sharma |
Screening OPD OPD no. 5 7 of All India Institute Of Ayurveda |
6th Floor Room no. 622(Seminar Hall) Department Of Swasthavritta All India Institute Of
Ayurveda Gautampuri
Sarita Vihar New Delhi
110076 South DELHI
South
DELHI
South
DELHI |
8527712731
nikhisharmadelhi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: VATAJAGRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bilvadi avaleha , Reference: Sahasrayogam Leha prakarana 1, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Luke warm water ), Additional Information: Bilvadi avaleha has been given orally twice a day after food with lukewarm water for 12 weeks | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Shatkarma (laghushankaprakshalan), Pathya/Apathya:yes, Pathya:Pathya
Langhan,shali,shashtik,lajmanda,masura,arhar,aja dugdha, takra,moong dal,til taila
,madhu,dadima,jamun,dhaniya,sura,kapitha,changer, Apathya:Apathya
Ratrijagran,ambupan,veganigrahan,viruddhabhojan,gehu,matar,udad,yava,rajma,adrak,makoye, bathua,aalu,loki,,lahshun,kheera,kakdi,dudha,guda,dahi ka pani | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Shatkarma and bilvadi avaleha , Pathya/Apathya:yes, Pathya:Pathya
Langhan,shali,shashtik,lajmanda,masura,arhar,aja dugdha, takra,moong dal,til taila
,madhu,dadima,jamun,dhaniya,sura,kapitha,changer, Apathya: Apathya
Ratrijagran,ambupan,veganigrahan,viruddhabhojan,gehu,matar,udad,yava,rajma,adrak,makoye, bathua,aalu,loki,,lahshun,kheera,kakdi,dudha,guda,dahi ka pani |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ICD-11
Irritable bowel syndrome, constipation predominant (DD91.00)
Irritable bowel syndrome, diarrhoea predominant (DD91.01)
Irritable bowel syndrome, mixed type (DD91.02)
Irritable bowel syndrome, unsubtyped (DD91.03)
Irritable bowel syndrome, type unspecified (DD91.0Z)
Age: 18-50 years
Gender-both males & females.
Patients having pratyatma lakshana of Grahani Roga especially –Atisrushtam malapravritti, Ativibadhham malapravritti, Atidravam malapravritti, Udara Shula (pain in abdomen), Anaha (distention of abdomen), Mala Tyaga Asantushti (dissatisfaction after defecation), Kapha Nihssarana (mucus in stool), Udara Atopa (tympanitis), Bhojanopranta Mala Tyaga (defecation after taking meals), Shuktpaka, Mana sadnam, Kruchapaka, Alteration of bowel habit (Shushka, Tanu, Apkwa, Phenyukta Malapravrutti)&
The patients who are diagnosed with IBS according to standard ROME IV criteria.
Patient with symptom onset at least 6 months prior to diagnosis.
Willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
Previously diagnosed cases and history of Ulcerative colitis, Crohn’s disease, gastric ulcerations,
Intestinal tuberculosis and other inflammatory bowel conditions.
Mixed infection with parasites such as round
worms, hook worms, & lactose intolerance patients.
Patients with evidence of malignancy.
Patients with Diabetes Mellitus. Patient with poorly controlled Hypertension
Abuse of drug or alcohol.
Presence of other somatic or mental disorder requiring medication.
Patients on prolonged medication with NSAIDs, analgesics or any other drugs that may have an influence on the outcome of the study.
Pregnant & lactating women.
Systemic disorders like respiratory, cardiac, renal, nervous, Degenerative disorders
BMI above 40
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 75% reduction in signs and symptoms of vataj ggrahani roga as well IBS Severity Score Scale(IBS SSS). |
At Baseline, 14th day-28th day-42nd day-56th
day-70th day-84th day and at the end of follow
up after 18th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement in the quality of life |
At Baseline, 14th day-28th day-42nd day-56th
day-70th day-84th day and at the end of follow
up after 18th week |
|
|
Target Sample Size
|
Total Sample Size="69"
Sample Size from India="69"
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)
|
02/12/2024 |
| 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="2"
Months="0"
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
|
This research will involve practice of laghushankhprakshalan and the patient visit the hospital in morning once in a week for the practice for three months. Patient will be asked for follow-up in every 2 weeks (visit to collect the drug)
This is one of the common clinical problems among patients attending gastroenterology clinics. The main clinical features of this ailment are abdominal pain associated with an altered bowel habit (may present with diarrhea or constipation or intermittently both) in the absence of any structural pathology. And the management of this disease is having limitations in the present scenario of the contemporary science.
Ayurveda has solutions for lifestyle functional disorders like irritable bowel syndrome. In the beginning of last century, influenced by the developments in modern medicine, some Ayurvedic experts attempted to enrich Ayurveda without losing its basic concepts.
after doing Shankha Prakshalana one feels very light and also a sense of rejuvenation in the body, whereas after taking the purgatives a feeling of heaviness, weakness and dullness in the body occurs.
|