| CTRI Number |
CTRI/2025/02/080875 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the efficacy of oral administration of yavani Choorna with saindhav in purushaj krimi |
|
Scientific Title of Study
|
A Randomized open labelled controlled clinical trial to assess an efficacy of yavani choorna with saindhav in purushaj krimi with special reference to ascaris lumricoides |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aniket Laxman Devhade |
| Designation |
PG Scholar |
| Affiliation |
Siddhkala ayurvedic mahavidyalay pimparne road sangamner 422605 |
| Address |
Ground floor Opd number 4 kaumarbhritya Department siddhkala ayurved mahavidyalay, and research centre pimparne raod Sangamner
Ground floor Opd number 4 kaumarbhritya Department siddhkala ayurved mahavidyalay, and research centre pimparne raod Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
08390349502 |
| Fax |
|
| Email |
aniketdevhade2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Prabhakar bholane |
| Designation |
professor |
| Affiliation |
Siddhkala hospital |
| Address |
Ground floor Opd number 4 kaumarbhritya Department siddhkala ayurved mahavidyalay, and research centre pimparne raod Sangamner
Ground floor Opd number 4 kaumarbhritya Department siddhkala ayurved mahavidyalay, and research centre pimparne raod Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
08390349502 |
| Fax |
|
| Email |
drrajeshbholane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Aniket Laxman Devhade |
| Designation |
PG Scholar |
| Affiliation |
Siddhkala hospital |
| Address |
Ground floor Opd number 4 kaumarbhritya Department siddhkala ayurved mahavidyalay, and research centre pimparne raod Sangamner
Ground floor Opd number 4 kaumarbhritya Department siddhkala ayurved mahavidyalay, and research centre pimparne raod Sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
08390349502 |
| Fax |
|
| Email |
aniketdevhade2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala ayurved mahavidyalaya and research centre Samgamner pimparne road sangamner khurda 422605 district ahemadnagar Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Aniket Laxman Devhade |
| Address |
Ground floor Opd no 4 kaumrbhrutya tantra department ground floor Siddhkala ayurved mahavidyalay and reserch centre Sangamner khurd 422605 district ahemadnagar Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Aniket devhade |
Siddhkala ayurved mahavidyalay and reaserch center pimparne road sangamner 422605 |
Ground floor Opd no 4 kaumarbhrutya tantra department ground floor Siddhkala ayurved mahavidyalay and research centre pimprane road Sangamner
Ahmadnagar
MAHARASHTRA |
08390349502
aniketdevhade2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of ayurveda research and statistics committee of Siddhakala ayurved mahavidyalaya sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B779||Ascariasis, unspecified. Ayurveda Condition: PURISHAJAKRUMIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tab Albendazole 400mg | | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yavani churna with saindhav, Reference: Bhaishajya ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 3 to 8 years irrespective of Gender, religion,
socio- economic status and food habits.
2. Children having Udara shoola in association with two or more
generalsign and symptoms of Krimi.
3. Diagnosed children of Ascaris lumbricoides after clinical
assessment and screening for microscopic stool examination |
|
| ExclusionCriteria |
| Details |
1.Infestation of ascariasis with complication such as intestinal
obstruction, ascariasis pneumonia etc.
2. Children suffering from any other systemic disorder along with
Ascaris lumbricoides.
3. Microscopic stool examination positive to ova or cyst of worms
other than Ascaris lumbricoides.
4. Microscopic stool examination positive to ova and cyst of
Ascaris lumbricoides in association with other worms |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the effect of oral administration of effect of yavani churna with Saindhav in purishaj Kirmi |
3rd 7th and 15th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Atisar
Udharshool
Malavivarnata
Sadan
Bhram
Bhaktdevsh |
3rd 7th & 15th 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 |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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="6"
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
|
To study is a Randomized open labelled controlled clinical trial to assess an efficacy of yavani choorna with saindhav .15 days 80 patients with purushaj krimi and also effect of Ascaris lumricoides To study the effect on sign and symptoms of disease To study the reoccurance of disease |