| CTRI Number |
CTRI/2023/10/058271 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [pain management through oral medication ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of stomachache |
|
Scientific Title of Study
|
An Experimental And Clinical Pilot Study To Evaluate The Antispasmodic Effect Of Alcoholic Extract Of Bhrahmi(Bacopa Monnieri) Capsule In Abdominal Colic. |
| 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 ULLAS MANUBHAI SENGAL |
| Designation |
PG SCHOLER |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY |
| Address |
OPD NO 106, PARUL AYURVEDA HOSPITAL, PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY, LIMDA, VADODARA
SALYATNTRA DEPARTMENT, PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY, LIMDA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
7621925322 |
| Fax |
|
| Email |
sengalullas9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Daga |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY |
| Address |
Opd No 106, Parul Ayurveda Hospital, Parul Institute Of Ayurveda, Parul University, Limda, Vadodara
Shalyatantra Department, Parul Institute Of Ayurveda, Parul University, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9413662079 |
| Fax |
|
| Email |
harish.daga26839@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ULLAS MANUBHAI SENGAL |
| Designation |
PG SCHOLER |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY |
| Address |
Opd No 106, Parul Ayurveda Hospital, Parul Institute Of Ayurveda, Parul University, Limda, Vadodara
Shalyatantra Department, Parul Institute Of Ayurveda, Parul University, Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7621925322 |
| Fax |
|
| Email |
sengalullas9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurveda, Parul university, Limda, Vadodara. |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurveda |
| Address |
Parul Ayurveda Hospital, Parul Institute Of Ayurveda, Parul University, Limda, Vadodara |
| 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 Ullas Manubhai Sengal |
Parul Institute of Ayurveda |
Opd No 106(Shalya
Tantra),Opd No
-105(Panchakarma)
Opd No-,116
(Kayachikitsa) Opd
No-112,108 (Shalakya
Tantra), Ipd Shalya
Ward No-302,303,306
To 309, Panchakarma
And Kayachikitsa Ipd
Ward No 201,205,206,207 And Parul University Associated Hospitals ,Parul
University, Post- Limda
,Pin-391760, Ta-Waghod
Ia,Vadodara,Gujarat
Vadodara
Gujarat
Vadodara
GUJARAT |
7621925322
sengalullas9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee for human research, Parul institute of Ayurveda,Parul univesity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K812||Acute cholecystitis with chronic cholecystitis. Ayurveda Condition: UDARA/UDARAROGAH, (2) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: ASMARI, (3) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, (4) ICD-10 Condition:R108||Other abdominal pain. Ayurveda Condition: SULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhrahmi alcoholic extract capsule, Reference: su chi chap 7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 350(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: Bhrahmi alcoholic extract capsule |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having age in between 18 to 80 years.
2. Patient with abdominal colicky pain without needing of immediate surgical
intervention.
3. Patients with Multiple urinary calculi (unilateral or bilateral), Cholecystitis and
Cholelithiasis, abdominal cramps, hepato colicky pain, dysmenorrhoea.
4. Patient of both genders taken irrespective of caste, religion, and socio-economic status |
|
| ExclusionCriteria |
| Details |
1. Renal or Ureteric Calculus with severe Hydronephrosis.
2. Obstructive renal calculi with severe infection.
3. Obstructive jaundice.
4. Patient who needs immediate surgical intervention like complete bowel obstruction.
5. Chronic systemic illness like malignancy & positive HIV, HBSAG, HCV. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of reduction of abdominal pain after 24 hours |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of pain after giving medication 3 hours, 6 hours, 12 hours |
3,6 and 12 hours |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
05/10/2023 |
| 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="1" |
|
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
|
Abdominal colicky pain is very frequently seen in many surgical conditions likes urinary Calculus, hepato-colicky, intestinal colicky pain, abdominal cramps, dysmenorrhoea. Abdominal pain is that you feel anywhere between your chest and groin. This is often referred to as the stomach region or belly. Main differential diagnosis of abdominal pain could be urinary calculus, appendicitis, Cholecystitis, Bowel obstruction, Pancreatitis, Chronic functional abdominal pain, Constipation. Most of the pain can be seen as spasmodic pain as there is smooth muscle spasm. In Ayurved there is no specific word for spasmodic pain but abdominal pains are referred as udarshula that most of the time is colicky in nature. One such very painful condition referred as if pain experienced as if death. Pain given by yama (God of death). Antispasmodic drugs used in modern science in the form of oral, intravenous & intramuscular drugs in the abdominal colic, but frequent use of NSAIDS & Antispasmodic drugs may lead to complications due to their ill effect like chronic kidney disease and moreover in chronic kidney disease the more use of analgesic drugs are contraindicated. Ayurvedic medications with shoolhara properties are mentioned in the ashmari chikitsa and Udarshula rogadhikar like Brahmi, sunthi, trivrut, haritak,etc are mentioned in samhitas. |