| CTRI Number |
CTRI/2024/09/073537 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of seeds Of Mimosa pudica in pravahika (ulcerative colitis) |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of seeds of Mimosa pudica in pravahika w.s.r. To Ulcerative Colitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chander Shekhar Sharma |
| Designation |
Professor |
| Affiliation |
Dayanand Ayurvedic College, jalandhar |
| Address |
Dayanand Ayurvedic College, Mahatma Hans Raj Marg, GT Road Jalandhar.
Punjab 144008
Jalandhar
PUNJAB
144008
India |
| Phone |
9417785499 |
| Fax |
|
| Email |
shekhars76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chander Shekhar Sharma |
| Designation |
Professor |
| Affiliation |
Dayanand Ayurvedic College, jalandhar |
| Address |
Dayanand Ayurvedic College, Mahatma Hans Raj Marg, GT Road Jalandhar.
Punjab 144008
Jalandhar
PUNJAB
144008
India |
| Phone |
9417785499 |
| Fax |
|
| Email |
shekhars76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chander Shekhar Sharma |
| Designation |
Professor |
| Affiliation |
Dayanand Ayurvedic College, jalandhar |
| Address |
Dayanand Ayurvedic College, Mahatma Hans Raj Marg, GT Road Jalandhar.
Punjab 144008
Jalandhar
PUNJAB
144008
India |
| Phone |
9417785499 |
| Fax |
|
| Email |
shekhars76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar (Pb), PIN CODE- 144008,INDIA |
| Microbes Formulas |
|
|
Primary Sponsor
|
| Name |
Microbes formulas |
| Address |
Garry & Sun, 1030 Matley Lane, Unit A Reno, Nevada 89502 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Chander Shekhar Sharma |
Dayanand Ayurvedic College, Jalandhar, Punjab |
Room no- 20, Department of Kayachikitsa, MC DAV Hospital Dayanand Ayurvedic College, Mahatma Hans Raj Marg, GT Road,Jalandhar, Punjab, 144008
Jalandhar
PUNJAB |
9417785499
shekhars76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAV Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K519||Ulcerative colitis, unspecified. Ayurveda Condition: PRAVAHIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mimosa pudica, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 Yrs to 60 Yrs
2. Gender: Male, female, transgender
3.Must sign the informed consent form
4. Documented diagnosis (based on Ayurvedic criteria, Sigmoidoscopy and biopsy) of ulcerative colitis
5. If treated with oral corticosteroids, dose must not increase 20 mg per day of Prednisolone or equivalent. |
|
| ExclusionCriteria |
| Details |
1. Severe ulcerative colitis indicated by Disease Activity Index score of greater than 10
2. Presence of any other medical condition.
3. Participants receiving therapy with cyclosporin, anti-TNF therapy, or methotrexate within the last 2 months of screening.
4. History of chronic liver disease or baseline liver chemistries greater than the upper limit of normal
5. Diabetes mellitus requiring hypoglycemic agents
6. Has any of the following laboratory abnormalities: WBC < 3,000 per uL, Neutrophil < 1,000 cell/cu.mm, Platelets <75,000 per uL.
7. Participant is female and is pregnant or currently breastfeeding
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Frequency of stool (Urgency)
2. Blood in stool (Bloody diarrhea)
3. Pain abdomen and discomfort (Tenesmus)
4. Body strength
5. Weight loss
6. Appetite
7. Mental status
8. Sigmoidoscopy (Before and after the study)
9. Biopsy (Before and after the study) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in hospital visits after completing the trial |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study patient will be selected from OPD of Kaya chikitsa and Panchakarma of M.C. DAV hospital, Jalandhar. Patient will be selected on the basis of Inclusion and exclusion criteria. Routine investigations will be carried out before enrolling patient for the study. Medicine (Lajjalu seeds) 2 gm tid (6gm daily) will be given to the patient for 8 weeks and the efficacy of Lajjalu seeds will be evaluated. Patient will be assessed every two weeks and 2 weeks after completion of study.
|