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CTRI Number  CTRI/2024/10/076015 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 23/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of NIMBAPANCHAKA CHURNA in the management of Purishaja Krimi (Helminthic Infestation )in children.  
Scientific Title of Study   Randomized Controlled Clinical Study to Evaluate the Efficacy of NIMBAPANCHAKA CHURNA in the management of Purishaja Krimi in children w.s.r. to Ascaris lumbricoides. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhagyashree Jagdish Nawlani 
Designation  MD Scholar, kaumarbhritya 
Affiliation  Chatrapati Shahu Maharaj Shikshan Sansthas Ayurveda Mahavidyalaya 
Address  OPD NO.14, Balrog department, Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Paithan Road,Aurangabad Aurangabad MAHARASHTRA

Aurangabad
MAHARASHTRA
431011
India 
Phone  9175046111  
Fax    
Email  nawlanibhagyashree@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  VD.Karuna Ratnaparkhi  
Designation  Head of Department, Kaumarbhritya  
Affiliation  Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya  
Address  OPD NO.14, Balrog department, Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Paithan Road,Aurangabad

Aurangabad
MAHARASHTRA
431011
India 
Phone  9421771722  
Fax    
Email  karunaratnaparkhi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhagyashree Jagdish Nawlani 
Designation  MD Scholar, Kaumarbhritya 
Affiliation  Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya  
Address  OPD NO.14, Balrog department, Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Paithan Road,Aurangabad Aurangabad MAHARASHTRA

Aurangabad
MAHARASHTRA
431011
India 
Phone  9175046111  
Fax    
Email  nawlanibhagyashree@gmail.com  
 
Source of Monetary or Material Support  
Chatrapati Shahu Maharaj Shikshan Sansthas Ayurveda Mahavidyalaya  
 
Primary Sponsor  
Name  Bhagyashree Jagdish Nawlani 
Address  Chatrapati Shahu Maharaj Sikshan Santhas Ayurved Mahavidyalaya and Rugnalaya kanchanwadi, Paithan Road, Aurangabad, 431011 
Type of Sponsor  Other [[self]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhagyashree Jagdish Nawlani  Chatrapati Shahu Maharaj Shikshan Sansthas Ayurveda Mahavidyalaya and Rugnalaya  OPD No 14, Department of Kaumarbhritya, Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya and Rugnalaya kanchanwadi, Paithan Road, Aurangabad, 431011
Aurangabad
MAHARASHTRA 		 09175046111

nawlanibhagyashree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee Chatrapati Shahu Maharaj sikshan Sansthans Ayurveda Mahavidyalaya and Rugnalaya kanchanwadi Aurangabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B779||Ascariasis, unspecified. Ayurveda Condition: PURISHAJAKRUMIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Nimbapanchaka churna, Reference: Yogaratnakar , krimiroga chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.25(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Palashbeej churna, Reference: Yogaratnakar krimiroga chikitsa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.25(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -madhu ), Additional Information: -
Intervention  NIMBAPANCHAKA CHURNA  Nimbapanchaka churna will be administered to the patients. Dose- 2.25 gm to 9 gm in 2 divided doses as per age. 1500 gm for 1 year then increase in dose by 750 mg every year upto 12 years 
Comparator Agent  PALASHBEEJ CHURNA  Palashbeeja churna will be administered to the patients. Dose- 2.25gm to 9gm in two divided doses as per the age of patients. 1500gm for 1 year of age then increase in dose by 750 gm per year upto 12 years 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1) Patientsirrespective of their gender, religion, & socioeconomic status
2)patients exhibiting symptoms of purishaja krimi mentioned in texts like udarshool, agnimandya, panduta, gudakandu 
 
ExclusionCriteria 
Details  1)Patients below age 3 and above 12 year.
2)Patients presenting with complications occurred
due to nematodes infestation
3)Any other systemic diseases which interfere with long term treatment.
4)Patient requiring surgical intervention.
5)Patient with symptoms like Abdominal pain affecting daily activities, Whitish pallor with skin pigmentation, Anal itching with disturbance of activity &sleep. 
 
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 
Udarshool (Abdominal pain)
Panduta (Pallor)
Agnimandya(Loss Of Apetite)
Gudakandu (Anal Itching) 		 Baseline- 7th, 14th day  
 
Secondary Outcome  
Outcome  TimePoints 

Panduta (Pallor)
Agnimandya(Loss Of Apetite)
 		 Baseline- 7th, 14th 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 3 
Date of First Enrollment (India)   10/11/2024 
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="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  

Helminthiasis is the most common paediatric complaint world wide. Most of the world’s population is infected with one of the most common parasites like thread worms, round worms, hook worms, tape worms. The complaints towards the infestation of intestinal worms come with greater incidence in paediatric practice.

        Use of uncovered food or improper washing of food materials, poverty, ignorance, lack of hygiene maintenance, bad sanitation etc. are the important factors for spreading helminthic infection in developing countries like India.

         Charak, Sushruta, Vagbhata, Madhavnidana, Sharangdhara,Yogratnakar, Bhavprakasha, etc. have given wide description about krimi.

        Total 20 krimis are mentioned and are classified as:-

A) Bahya

B) Abhyantara krimi.

        Abhyantar krimi further divided into 3 types:-

A) Kaphaja

B) Raktajka

C) Purishaja krimi.

     Chikitsa has been evolved in krimiroga in contex viz:-

A) Apakarshana

B) Prakritivighataka

C) Nidan parivarjana.

      In Ayurveda many krimighna drugs are mentioned. In this regard ‘Nimbapanchaka Churna’, having krimighna property mentioned in “Yogaratnakara” ( shloka -04 in Krimirog chikitsa Adhyaya) is selected.

        All that drugs possess properties mentioned for krimighna drugs.

 

 
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