| CTRI Number |
CTRI/2025/01/079799 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| 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 efficacy of Yavanikhandav Churna
in the management of Pandu Vyadhi with special reference to Iron Deficiency Anemia in children between age group 1 to 12 year |
|
Scientific Title of Study
|
Randomized controlled trial to evaluate the efficacy of Yavanikhandav Churna
in the management of Pandu Vyadhi with special reference to Iron Deficiency
Anemia in children. |
| 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 Nikhil Ramesh Pawar |
| Designation |
MD Schholar Kaumarbhrityatantra |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8087901875 |
| Fax |
|
| Email |
nikhilpawar226@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramchandra Pnadurang Babar |
| Designation |
Professor of department of Kaumarbhritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8275459237 |
| Fax |
|
| Email |
ramchandrababar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramchandra Pnadurang Babar |
| Designation |
Professor of department of Kaumarbhritya |
| Affiliation |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
MAM S Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8275459237 |
| Fax |
|
| Email |
ramchandrababar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaumarbhritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra Malwadi 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 Nikhil Ramesh Pawar |
Sane Guruji Arogya Kendra |
OPD NO 13 Department of Kaumarbritya Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
8087901875
nikhilpawar226@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavanikhandav Churna , Reference: sharangdhara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 350(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Study will be done for 30 days | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous Ascorbate | Ferrous Ascorbate syrup will be given for 30 days to group A with dose of 3 mg/kg/day |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Iron Deficency Anemia Diagnosed patients will be included
2. Patients between Hb 09 to12 gm per dl.
3. Patient between the age group of 1 to 12 years will be taken.
4. Primarily the patients will be selected on the basis of Hb percentages found in laboratory
investigations also classical symptoms of Pandu Roga.
5. Patients having any 5 or more than 5 lakashanas of the following will be
enrolled in the study
Panduta (Pallor)
Shrama (Reduced exercise capacity)
Gatrasada (Fatigue)
Gatrashoola (Bodyache)
Shwasa (Breathlessness)
Hridyaspandana (Palpitation)
Aalasya (Drowsiness)
Shiroruja (Headache)
Aruchi (Anorexia)
Dourbalya (Weakness)
Akshikut soth (Eye swelling)
Karnashweda(Tinitus)
|
|
| ExclusionCriteria |
| Details |
1. Drug Allergy
2. Hb less than 9 mg per dl
3. Systemic Diseases
4. Bleeding Disorder
5. Those who are not willing to participate in trial and not ready to give written consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Yavanikhandav Churna in the management of Pandu Vyadhi with special reference to Iron Deficiency Anemia in children |
Treatment will be given for 30 days.Ferrous ascorbate will be given to one group and yavanikhandav churna will be given to another group.
Followup will be taken on 7th 15th and 30th day.
Assesment will be done by objective and subjective parameters.
Final observation will be recorded after completion of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Litrature Study of Pandu in Paediatric age group.
To observe the adverse effect if any |
Study will be done using the ayurvedic granthas and modern text.
Preparation of drugs will be done according to standard procedure.
During treatment observation will be done on 7th, 15th and 30th day. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2025 |
| 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="0"
Months="0"
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
|
This is a Comparative Clinical Study between the efficacy of Yavanikhandav Churna and Ferrous Ascorbate Syrup in the management of Pandu vyadhi with special refrence to Iron Deficency Anemia in children from age group 1 to 12 years. Primary Objective is to Comparative between Yavanikhandav Churna and Ferrous Ascorbate Syrup in children from age group 1 to 12 years for 30 days. Assesment of signs and symptoms will be done and observation will be drawn from the outcome of the Patient. |