| CTRI Number |
CTRI/2026/01/102359 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to assess the role of clinical pharmacists in improving nutrition among malnourished children in rural communities |
|
Scientific Title of Study
|
Impact of clinical pharmacist led interventions on Paediatric malnutrition in rural communities: prospective interventional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| hajiafshin268@gmail.com |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SMahaboob Basha |
| Designation |
Researcher |
| Affiliation |
Balaji college of pharmacy |
| Address |
Balaji college of pharmacy
Rudrampeta
Anatapur
Andha Pradesh
515001
INDIA
Rudrampeta
Anatapur
Andha Pradesh
515001
INDIA
Anantapur
ANDHRA PRADESH
515001
India |
| Phone |
7993638807 |
| Fax |
|
| Email |
7993638807basha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTRajavardhana |
| Designation |
Proffesor |
| Affiliation |
Balaji college of pharmacy |
| Address |
Balaji college of pharmacy
Rudrampeta
Ananthapuramu
Andhrapradesh
515001
INDIA
Balaji college of pharmacy
Rudrampeta
Ananthapuramu
Andhrapradesh
515001
Anantapur
ANDHRA PRADESH
515001
India |
| Phone |
9533260926 |
| Fax |
|
| Email |
rajavardhana2@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTRajavardhana |
| Designation |
Proffesor |
| Affiliation |
Balaji college of pharmacy |
| Address |
Balaji college of pharmacy
Rudrampeta
Ananthapuramu
Andhrapradesh
515001
Balaji college of pharmacy
Rudrampeta
Ananthapuramu
Andhrapradesh
515001
ANDHRA PRADESH
515001
India |
| Phone |
9533260926 |
| Fax |
|
| Email |
rajavardhana2@gamil.com |
|
|
Source of Monetary or Material Support
|
| S.MahaboobBasha
Balaji College of Pharmacy
Alamuru road,Rudrampeta,Ananthapuramu
INDIA
515001
|
|
|
Primary Sponsor
|
| Name |
SMahabbob Basha |
| Address |
Balaji college of pharmacy
Rudrampeta
Ananthapuramu
Andhra pradesh
515002 |
| Type of Sponsor |
Other [Self sponsered] |
|
|
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 I Murali |
Anganwadi Centre / schools |
Vimala farooq nagar
515002
Rudrampeta
Ananthapur
Andhrapradesh
515004
Anantapur
ANDHRA PRADESH |
09346074416
muraliiduguru14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BALAJI COLLEGE OF PHARMACY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with malnourished |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
clinical pharmacist intervention |
Impact of clinical pharmacist led approaches on malnutrition in rural communities |
| Comparator Agent |
NIL |
Six months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6 months to 5 years
Diagnosed or screened as malnourished
Both Severe Acute Malnutrition and Moderate Acute Malnutrition(based on WHO growth standard)
Parents/guardians willing to give informed consent and Ethical requirement
|
|
| ExclusionCriteria |
| Details |
Children with chronic illnesses, primary surgical patients
-Children on special dietary restrictions
-Parents not willing to participate
-severe genetic syndromes (e.g.: trisomy with severe cardiac defects) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in nutritional status of malnourished children (6–59 months)
assessed by change in anthropometric indices from baseline to 6 months. |
Baseline- 4 weeks , 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="234"
Sample Size from India="234"
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)
|
10/02/2026 |
| 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
|
Clinical pharmacist-led interventions support early identification and effective management of paediatric malnutrition in rural communities. Through caregiver education and counselling, pharmacists improve feeding practices, nutrition awareness, and adherence to supplements. They optimize micronutrient therapy and prevent drug–nutrient interactions. Regular follow-up by clinical pharmacists contributes to improved growth parameters and reduced malnutrition-related complications |