| CTRI Number |
CTRI/2025/04/085748 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
It is a comparison of two Ayurvedic drug formulations Dhatri Loh and Nisha Loh in iron deficiency anemia in school going children. |
|
Scientific Title of Study
|
Comparitive study of Nisha Loh and Dhatri Loh in pandu w.s.r to childhood iron deficiency anemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukriti |
| Designation |
PG scholar |
| Affiliation |
Abhilashi Ayurvedic College and research institute |
| Address |
Department of Kaumarbhritya
Abhilashi Ayurvedic College and Research Institute
Chail Chowk
Mandi
Mandi
HIMACHAL PRADESH
175028
India |
| Phone |
9816977469 |
| Fax |
01907250405 |
| Email |
sukriti1604@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Sharma |
| Designation |
Professor and Head of Department |
| Affiliation |
Abhilashi Ayurvedic College and research institute |
| Address |
Department of Kaumarbhritya
Abhilashi Ayurvedic College and Research Institute
Chail Chowk
Mandi
Mandi
HIMACHAL PRADESH
175028
India |
| Phone |
7018720016 |
| Fax |
01907250405 |
| Email |
monikasharmaau89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sukriti |
| Designation |
PG scholar |
| Affiliation |
Abhilashi Ayurvedic College and research institute |
| Address |
Department of Kaumarbhritya
Abhilashi Ayurvedic College and Research Institute
Chail Chowk
Mandi
Mandi
HIMACHAL PRADESH
175028
India |
| Phone |
9816977469 |
| Fax |
01907250405 |
| Email |
sukriti1604@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abhilashi Ayurvedic College and Research Institute
Chail Chowk
Mandi, Himachal Pradesh
India
175028 |
|
|
Primary Sponsor
|
| Name |
Sukriti |
| Address |
PG Scholar
Department of Kaumarbhritya
Abhilashi Ayurvedic College and Research Institute
Chail Chowk
Mandi |
| 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 |
| Dr Sukriti |
Abhilashi Ayurvedic Hospital |
OPD Number 1
Department of balrog
Chail Chowk
MANDI
Mandi
HIMACHAL PRADESH |
9816977469
01907250405
sukriti1604@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABHILASHI AYURVEDIC COLLEGE AND RESEARCH INSTITUTE INSTITUTIONAL EHTICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DHATRI LOH, Reference: CHAKRADATTA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 150(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: HONEY), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: NISHA LOH, Reference: RASENDRA SAAR SANGRAHA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 150(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: HONEY), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
We will be including children between 7 to 11 years of age, of either sex, having hemoglobin levels between 7 to 10 g/dL, without any systemic illness or bleeding disorder. |
|
| ExclusionCriteria |
| Details |
AGE GROUP LESS THAN 7 AND GREATER THAN 11
HB LESS THAN 7 GM/DL OR GREATER THAN 10 GM/DL
SYSTEMIC ILLNESS
BLEDDING DISORDERS
FEMALES WHO HAVE ATTAINED MENARCHE |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in iron deficiency anaemia by rise in Hb |
Baseline 2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in cognitive functioning |
Second week & sixth week of trial |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="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
|
A number of formulations have been described in ancient texts for the treatment of iron deficiency anemia. This study is designed to evaluate the difference in results between Dhatri Loh and Nisha Loh. |