| CTRI Number |
CTRI/2025/02/080219 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| 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
|
Add on effects of Kharjuradi Modaka in the management of Pandu Roga with special reference to Iron Deficiency Anemia in children . |
|
Scientific Title of Study
|
Add on effects of Kharjuradi Modaka in the management of Pandu Roga 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 |
Praharsh Verma |
| Designation |
PG Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of kaumarbhritya balroga FoAy IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8224901666 |
| Fax |
|
| Email |
praharshvarma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi shankar Khatri |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of kaumarbhritya balroga FoAy IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9549182589 |
| Fax |
|
| Email |
drrskhatri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi shankar Khatri |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of kaumarbhritya balroga FoAy IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9549182589 |
| Fax |
|
| Email |
drrskhatri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital,institute of medical sciences Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
faculty of ayurveda ims banarass hindu university |
| Address |
Department of kaumarbhritya balroga faculty of ayurveda IMS Banaras hindu university |
| 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 |
| Praharsh Verma |
Sir Sunderlal Hospital |
Sir Sunderlal hospital,25 no opd,department of kaumarbhritya balroga faculty of ayurveda ,ims, banaras hindu university,Varanasi
Varanasi
UTTAR PRADESH |
8224901666
praharshvarma@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:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Kharjuradi Modaka, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 25(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navayasa lohawith Kharjuradi Modaka , Reference: Charak chikitsa 16/70-71, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Ferrous ascorbate+folic acid with Kharjuradi Modaka , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
i.Patients diagnosed with Pandu (Iron Deficiency Anaemia).
ii.Patients of either sex of age group 5-14 years.
iii.Patients with Hb% within the range of 8 - 11gm/dl.
iv. Parents submitting written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
i.Patients with anemia of origin other than Iron Deficiency.
ii. Patients who refuse for investigations, on follow-up were dropped from the study.
iii.Patients with Hb% less then 8gm/dl and more then 11gm/dl will not included in the study.
iv.Patients suffering with any serious infection.
Patients showing signs of intolerance to the drug or develop any other major disease requiring intensive treatment or stoppage of the treatment of anemia (trial or control) were dropped from study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hb% |
significant changes in hb% over follow up at 30th day and 60th day of administering medicine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Symptomatic relief
2) Improvement in Biochemical & hematological parameters |
significant changes in hb% over follow up at 30th day & 60th day of administering medicine |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/02/2025 |
| 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
|
OBJECTIVES – • To assess the additive effect of Kharjuradi Modaka in Pandu roga (Iron Deficiency Anemia). • To Analyze study of Kharjuradi Modaka and its ingredients. • To compare the additive effect of Kharjuradi Modak with Navayasa lauha & standard iron therapy in Pandu roga (Iron Deficiency Anemia). Studying and recording the additive effect of Kharjuradi Modaka on biochemical parameter in Pandu Roga (Iron Deficiency Anemia). |