| CTRI Number |
CTRI/2021/12/038769 [Registered on: 20/12/2021] Trial Registered Prospectively |
| Last Modified On: |
17/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy study of castor oil as purgative at two different administration time as before dinner and at bed time in management of constipation. |
|
Scientific Title of Study
|
A comparative clinical trial to evaluate the efficacy of Eranda Sneha (Castor oil) at two different
administration time as Pragbhakta and Nishi Kaala as Virechan Dravya in management of Malavarodha. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr POONAM NARAYAN MARGAJ |
| Designation |
M.D. Scholar Ayurveda Samhita and Siddhant |
| Affiliation |
M.A.Ms Sumatibhai Shah Ayurved Mahavidyalaya, Pune |
| Address |
Department of Ayurveda Samhita and Siddhant,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8007202986 |
| Fax |
|
| Email |
poonammargaj3470@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NILESH KULKARNI |
| Designation |
Professor |
| Affiliation |
M.A.Ms Sumatibhai Shah Ayurved Mahavidyalaya, Pune |
| Address |
Department of Ayurveda Samhita and Siddhant,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8805335512 |
| Fax |
|
| Email |
prof.dr.nileshkulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr POONAM NARAYAN MARGAJ |
| Designation |
M.D. Scholar Ayurveda Samhita and Siddhant |
| Affiliation |
M.A.Ms Sumatibhai Shah Ayurved Mahavidyalaya, Pune |
| Address |
Department of Ayurveda Samhita and Siddhant,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8007202986 |
| Fax |
|
| Email |
poonammargaj3470@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ayurveda Samhita and Siddhant,Sane Guruji Arogya Kendra,Malwadi Road Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya kendra |
| Address |
Sane Guruji Arogya kendra,Malwadi Road Hadapsar Pune |
| 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 POONAM NARAYAN MARGAJ |
Sane Guruji Arogya KendraSane Guruji Arogya Kendra,Malwadi Road Hadapsar Pune |
Department of Ayurveda Samhita and Siddhant,Attached OPD of Sane Guruji Arogya Kendra,Malwadi Road Hadapsar
Pune
MAHARASHTRA |
8007202986
poonammargaj3470@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: मलावरोध, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda Sneha (Castor oil), Reference: Classical Samhita, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna jala (lukewarm water)), Additional Information: Efficacy of drug at prabhakta kaala will be compared to nishi kaala |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having symptoms of Malavarodha as per mentioned Rome II criteria and ODS Longo score for constipation at least since 1 week but not manifested with any other classical disease. |
|
| ExclusionCriteria |
| Details |
1. IBS related patients
2. Patients diagnosed with piles
3. Pregnant and lactating female
4. Iron supplements
5. Intestinal obstruction and acute abdomen |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Eranda Sneha as Virechan dravya in management of Malavarodha when given at Pragbhakta Kaala than Nishi Kaala in a dose of 5 ml for duration of 7 days. |
The drug will be given for 7 days. Patient will be called for follow up on 8th day as last dose of medicine will be on 7th day at night and on 15th day to check the after effect of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of Malavarodha |
The drug will be given for 7 days. Patient will be called for follow up on 8th day as last dose of medicine will be on 7th day at night and on 15th day to check the after effect of drug |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/12/2021 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomised comparative clinical trial to evaluate the efficacy of Eranda sneha (castor oil) as Virechan dravya in management of Malavarodha when given at Pragbhakta and Nishi Kaala. Primary outcome of study will be the effect of Eranda sneha as Virechan dravya in management of Malavarodha when administred in Pragbhakta Kaala than Nishi Kaala in dose of 5ml for duration of 7 days. |