| CTRI Number |
CTRI/2025/01/079291 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha
Other (Specify) [Case Series] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on the Effectiveness of Chukku nei in the management of Mannun Paandu(Iron Deficiency Anemia) |
|
Scientific Title of Study
|
Preclinical and clinical evaluation of the effect on oral administration of Chukku nei in the management of Mannun Paandu(Iron Deficiency Anemia) among paediatric age group |
| 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 P JANNATH FIRTHOUSE |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli. |
| Address |
PG First Year,
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9367454064 |
| Fax |
|
| Email |
jannathsaji8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S GEETHA DEVI |
| Designation |
Associate Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli. |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7401757475 |
| Fax |
|
| Email |
geethadevis16@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S GEETHA DEVI |
| Designation |
Associate Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli. |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli.
TAMIL NADU
627002
India |
| Phone |
7401757475 |
| Fax |
|
| Email |
geethadevis16@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Government siddha medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu -627002 |
|
|
Primary Sponsor
|
| Name |
Dr P JANNATH FIRTHOUSE |
| Address |
Department of Kuzhanthai Maruthuvam, Branch IV,
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu, India.
|
| 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 P Jannath Firthouse |
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu, India. |
Department of Kuzhanthai Maruthuvam, Branch IV,
Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu, India.
Tirunelveli
TAMIL NADU |
9367454064
jannathsaji8@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chukku nei(Internal administration) |
Should be administered orally once a day after food for a period of 48 days. Dose:3 kalanju -15.3g (Depending upon the age and body weight of the child ,dose will be adjusted) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age: 6-12 years of Children
Sex: Both male and female children
Willing to attend the OPD and IPD
Hemoglobin level above 7 g/dl to 11.4 g/dl |
|
| ExclusionCriteria |
| Details |
Children below 6 years and above 12 years
Hemoglobin level less than 7 g/dl
Severe persistent anemia with Congestive heart failure and Hepatosplenomegalay
Children who are in need of red cell transfusion
Other types (Megaloblastic Anaemia, Hemolytic Anaemia, Thalassemia, Sickle cell
Anemia, Aplastic Anemia, Anemia of inflammation/infection, Anemia in renal and
liver disease, Sideroblastic Anemia) and Leukemia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will understand the effects of "Chukku nei" in the management of "Mannun Paandu (Iron Deficiency Anemia)" among paediatric age group |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/02/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
BACKGROUND Anaemia is defined as reduced haemoglobin count in blood below the lower limit of normal range for the age and sex of the individual. The normal range for 6 to 12 years aged children is 11.5 g/dl to 15.5 g/dl. According to WHO, iron deficiency is considered to be the most common cause of Anaemia. It affects approximately 8% to 9% of the world’s population. In our siddha literature, the symptoms mentioned for MANNUN PAANDU correlates with the symptoms of IRON DEFICIENCY ANAEMIA. Those symptoms include ingestion of non[1]nutritive substance, indigestion, flatulence, worms, fever and loss of weight. They are often associated with iron deficiency anaemia. Based on the above explanation and symptoms of the disease I have chosen the medicine CHUKKU NEI.
OBJECTIVE: The objective of the study is to evaluate the effect of "CHUKKU NEI†in the management of "MANNUN PAANDU (IRON DEFICIENCY ANAEMIA)†among paediatric age group
|