| CTRI Number |
CTRI/2021/08/035488 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
30/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Nelli Mulli Ilagam in the treatmentof Iron Deficiency Anaemia |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF SIDDHA HERBAL FORMULATION NELLI MULLI ILAGAM IN THE TREATMENT OF PITHA PAANDU (IRON DEFICIENCY ANAEMIA) |
| Trial Acronym |
CLINICAL STUDY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chithra MG |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 1, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium,
Chennai
Kancheepuram
TAMIL NADU
600047
India
Room No 1, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
600047
India
Kancheepuram
TAMIL NADU
Dr Chithra M G
India |
| Phone |
9677551634 |
| Fax |
22381314 |
| Email |
chithramanibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrT LAKSHMI KANTHAM MDS PhD |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 1,Department of Maruthuvam, National Institute of Siddha , Tambaram Sanatorium
Room no 1,Department of Maruthuvam, National Institute of Siddha , Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9025575185 |
| Fax |
22381314 |
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMGCHITHRA |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 1, Department of Maruthuvam,National Institute of Siddha,Tambaram Sanatorium.
Room no 1, Department of Maruthuvam,National Institute of Siddha,Tambaram Sanatorium.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9677551634 |
| Fax |
22381314 |
| Email |
chithramanibsms@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF MARUTHUVAM,AYOTHIDOSS PANDITHAR HOSPITAL,NATIONAL INSTITUTE OF SIDDHA,TAMBARAM SANATORIUM,CHENNAI - 600047 |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
ROOM NO 1, DEPARTMENT OF MARUTHUVAM,AYOTHIDOSS PANDITHAR HOSPITAL,NATIONAL INSTITUTE OF SIDDHA,TAMBARAM SANATORIUM, CHENNAI - 600047 |
| 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 |
| DrMGChithra |
AYOTHIDOSS PANDITHAR HOSPITAL |
Room no 1, Department of Maruthuvam,National Institute of Siddha,Tambaram Sanatorium.
Kancheepuram
TAMIL NADU |
9677551634
22381314
chithramanibsms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Submittted/Under Review |
| 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 |
Nelli Mulli Ilagam |
Nelli Mulli Ilagam in the treatment of Pitha paandu
Dosage : 8 gram twice a day
Days: 48 days
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with appropriate symptoms like pallor of skin, excessive of thirst, fatigue, blurred vision, giddiness, chest tightness, breathlessness, pungent or bitter taste, angular stomatitis, glossitis, cheilosis
Hb level less than normal range,
For male: 9-11gms/d1
For female: 8-10gms /dl
Abnormal peripheral smear study – Microcytic Hypochromic Anaemia
Patient willing to undergo blood investigation.
|
|
| ExclusionCriteria |
| Details |
Presence of any associated severe systemic illness like cancer, AIDS
Chronic Kidney Disease
Diabetes Mellitus
Pregnant women
Inherited defects like Sickle cell anaemia, Thalassemia, Aplastic anaemia
Patients not willing to give blood sample |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome will be assessed by comparing the pre and post treatment status of Peripheral smear and Haemoglobin level of the study subjects. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction of clinical symptoms
Improvement in complete blood count
Siddha basic principles like Envagai thervu, Neerkuri neikuri, Udal thaathukal in pitha paandu patients
The cofactors such as socioeconomic status, occupation, dietary habits, chronic blood loss conditions will be studied |
Fourty ninth day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/08/2021 |
| Date of Study Completion (India) |
24/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="18" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an interventional study in which 30 patients with any of the symptoms like pallor of skin, excessive thirst, giddiness, chest tightness, breathlessness, pungent or bitter taste, angular stomatitis, glossitis, fatigue will be selected based on inclusion and exclusion criteria. After enrolling the patients in the study, Nelli mulli ilgam 8 gram will be given twice a day for 48 days. After 48 days, patients will be asked to do blood investigations for any changes in it and absence of clinical signs and symptoms of Pitha paandu. |