| CTRI Number |
CTRI/2025/11/098015 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomised Control trial to Evaluate The Efficacy Of Vidangadi Choorna In Treatment Of Purishaj Krumi With Special Refrence To Intestinal Amoebiasis. |
|
Scientific Title of Study
|
A Controllrd Clinical Study To Evaluate The Efficacy Of Vidanagdi Choorna In Treatment Of Purishaj Krumi With Special Reference To Intestinal Amoebiasis |
| 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 Namrata Nanasaheb Dhavan |
| Designation |
PG Scholar |
| Affiliation |
M.A.Podar Hospital ,R.A.Podar GOVT(Ayu) College ,Worli , Mumbai |
| Address |
OPD No. 18,Kaychikitsa Department ,M.A.Podar Hospital , R.A.Podar Govt( Ayu ) College,Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
07028779316 |
| Fax |
|
| Email |
namratadhavan7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMeenakshi Rewdkar Kole |
| Designation |
Associate Professor |
| Affiliation |
M.A.Podar Hospital ,R.A.Podar GOVT(Ayu) College ,Worli , Mumbai |
| Address |
OPD No. 18,Kaychikitsa Department ,M.A.Podar Hospital , R.A.Podar Govt( Ayu ) College,Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9757476325 |
| Fax |
|
| Email |
drmrevadkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMeenakshi Rewdkar Kole |
| Designation |
Associate Professor |
| Affiliation |
M.A.Podar Hospital ,R.A.Podar GOVT(Ayu) College ,Worli , Mumbai |
| Address |
OPD No. 18,Kaychikitsa Department ,M.A.Podar Hospital , R.A.Podar Govt( Ayu ) College,Worli, Mumbai
MAHARASHTRA
400018
India |
| Phone |
9757476325 |
| Fax |
|
| Email |
drmrevadkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| OPD No.18 ,Kaychikitsa Department , M.A.Podar Hospital,R.A.Podar Govt (Ayu)College,Worli,Mumbai-18,400018 |
|
|
Primary Sponsor
|
| Name |
R.A.Podar Govt(Ayu)College ,worli,Mumbai-18 |
| Address |
R.A.Podar Govt(Ayu)College ,worli,Mumbai-18 Dr.Annie Besant Road Worli Mumbai 400018 |
| Type of Sponsor |
Government 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 |
| Namrata Nanasaheb Dhavan |
M A Podar Hospital |
OPD No. 18,Kaychikitsa Department ,M.A.Podar Hospital , R.A.Podar
Govt( Ayu ) College,Worli, Mumbai
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
7028779316
namratdhavan7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS committee of institution , R A Podar Govt Ayu college ,Worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:A063||Ameboma of intestine. Ayurveda Condition: KRUMIH/SANJATAKRUMI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vidangadi choorna , Reference: chakradatta , adhyay 7 shlok 6 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Takra ), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: vrundadi choorna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient Presenting With Sign And Symptom Any 2 of Following
1.Asnhatmalpravrutti
2.Adhman
3.Udarshool
Patient Having Stool With E. Histolytica Or Their Cyst Present In Stool . |
|
| ExclusionCriteria |
| Details |
1.Patient Having Fever,Cramping pain, Bloody Diarrhoea.
2.Patient Having Diseases Like TB,HIV.
3.Pregnant And Lactating Women.
4.Patient Having fisure or PR bleeding |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is reduction in adhman ,udarshool and frequency of stool . there is eradication of e. histolytica from stool . |
15 th day . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in digestion |
45 th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/12/2025 |
| 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="1"
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
|
To evaluate the efficacy of vidangadi choorna in purishaj
krimi with special reference to intestinal amoebiasis .
STUDY TYPE -
Randomised controlled clinical trial
TWO GROUPS -
Trial group - vidangadi choorna ( 3gm twice for 15 days with
takra)
Control group - vrundadi choorna ( 3gm twice for 15 days
with takra)
Objectives -
1.To evaluate the efficacy of vidangadi choorna in
intestinal amoebiasis in reducing dravmalpravrutti ,udarshool,adhman .
2. To evaluate the effect of vidangadi choorna on
E.Histolytica in stool routine microscopic examination.
Design Details - Randomised control clinical trial.
DURATION -45 days
SAMPLE SIZE -Total 80
( 40 for each group)
INCLUSION CRITERIA :-
1, Patients of age group 18-70yrs.
2.sex- all genders
3..patient presenting with sign and symptoms any 2 of
following
i.asnhatmalpravrutti
Ii. Adhman
iii.udarshool
3.patient having stool with E.histolytica or their cyst
present in stool
EXCLUSION CRITERIA:-
1.Patient having fever, cramping pain,bloody diarrhea .
2.patients having diseases like TB,HIV .
3.pregnant and lactating woman.
4. patient having fissure or pr bleeding . |