| CTRI Number |
CTRI/2022/12/048519 [Registered on: 27/12/2022] Trial Registered Prospectively |
| Last Modified On: |
29/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An ayurvedic formulation for iron deficiency anaemia in children. |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of vidangadi lauha in rasa pradoshaja pandu in children W.S.R to iron deficiency anaemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhilasha Sharma |
| Designation |
PG Student |
| Affiliation |
Sri Sri College of Ayurvedic Science & Research. |
| Address |
OPD No 9 Department of pg studies in Kaumarabhritya Sri Sri college of ayurvedic science and research hospital 21KM Kanakapura Road udayapura post OB Chudahalli Bengaluru Karnataka.
560082
india
Bangalore
KARNATAKA
560082
India |
| Phone |
9591769066 |
| Fax |
|
| Email |
abhilashas007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheer BR |
| Designation |
HOD & Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science & Research. |
| Address |
OPD No 9 Department of pg studies in Kaumarabhritya Sri Sri college of ayurvedic science and research hospital 21KM Kanakapura Road udayapura post OB Chudahalli Bengaluru Karnataka.
560082
india
Bangalore
KARNATAKA
560082
India |
| Phone |
9900175777 |
| Fax |
|
| Email |
sudheerbrao@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudheer BR |
| Designation |
HOD & Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science & Research. |
| Address |
OPD No 9 Department of pg studies in Kaumarabhritya Sri Sri college of ayurvedic science and research hospital 21KM Kanakapura Road udayapura post OB Chudahalli Bengaluru Karnataka.
560082
india
Bangalore
KARNATAKA
560082
India |
| Phone |
9900175777 |
| Fax |
|
| Email |
sudheerbrao@yahoo.co.in |
|
Source of Monetary or Material Support
Modification(s)
|
| OPD No 9 Department of pg studies in Kaumarabhritya Sri Sri college of ayurvedic science and research hospital 21KM Kanakapura Road udayapura post OB Chudahalli Bengaluru Karnataka.
560082 India |
|
|
Primary Sponsor
|
| Name |
Dr Abhilasha Sharma |
| Address |
OPD No 9 Dept of PG Studies in Kaumarabhritya Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakapura Road udayapura PO OB Chudahalli Bengaluru |
| 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 Abhilasha Sharma |
Sri Sri College of Ayurvedic Science and Research Hospital Bengaluru |
Opd no 9 department of pg studies in Kaumarabhritya Sri Sri college of Ayurvedic science and research hospital 21st km Kanakapura road udayapura post OB chudahalli Bangalore 560082
Bangalore
KARNATAKA |
9591769066
abhilashas007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: vidangadi lauha, Reference: chakradutta, pandurogadhikara chikitsa verse 34-35, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 140(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: guda haritaki, Reference: bhaishajya ratnavali chapter 12 verse 4, Route: Oral, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group between 10-16 years irrespective of religion, gender, and socio-economic status will be included.
2. Children with cardinal signs of iron deficiency anemia will be included.
3. Children with haemoglobin 8g/dl to12g/dl (mild to moderate anemia) and hematocrit less than 36% will be included.
4. Children with clinical features of Rasa Pradoshaja Pandu will be included.
|
|
| ExclusionCriteria |
| Details |
1. Children less than 10 years and more than 16 years of age will be excluded.
2. Children with severe anemia less than 8g/dl will be excluded.
3. Children with congenital anomalies will be excluded.
4. Children with inborn errors of metabolism will be excluded.
5. Other hemoglobinopathies like Thalessemia, Sickle cell anaemia etc. will be excluded.
6. Children with other systemic illnesses will be excluded.
7. Children with Mritbhakshana Janya Pandu will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment will be done as per the classical lakshanas of rasa pradoshaja pandu and grades will be given as per the WHO scoring methodology in ayurveda and lab investigations. |
assessment will be done on
0th day (before starting medication)
60th day (followup) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| investigations (haemoglobin percentage and complete blood count) will be done to assess iron deficiency anaemia. |
before intervention- 0th day
followup- 60th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
29/12/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Adolescence is a phase of transition from childhood to adulthood where there is a strong need of physical and mental support. Since there is a marked growth spurt at this phase, Nutritive substances such as Iron, Proteins and Vitamins like Vit. C, Vit. B12 and Folic acid are necessary for erythropoiesis. The deficiency of these substances leads to Nutritional deficiency anaemia. According to National Family Health Survey-4 anaemia in children can result in impaired cognitive performance, motor development, and scholastic achievement. Iron deficiency anaemia is the most common prevalent nutritional deficiency anaemia affecting children & adolescents worldwide. The epidemiological data shows an increased incidences of iron deficiency at 3 stages: Neonatal, in pre-school, and in adolescents. According to National Health Mission 2019-2020 index, Bengaluru holds 17th rank in the Anaemia Mukt Bharat, Karnataka has been asked to reduce the incidence of anaemia by 3% every year to achieve the goal by 2022. As per the study held at Rajarajeswari Medical College & Hospital Kambipura, Bengaluru, the prevalence of iron deficiency anaemia from the age of 10 years to 19 years was 47.7%. Adolescent group are highly prone to develop iron deficiency anaemia due to rapid pubertal growth. Hence, there is a strong need to approach this adolescent population through school visits, nutrition education and oral supplements. Iron deficiency anaemia can be correlated with RasaPradoshaja Pandu as per Ayurvedic classics. Mere iron supplementation may not be sufficient in this condition, but requires correction of Rasagni to improve iron absorption. Also iron supplements cause side-effects like epigastric irritation, constipation, nausea etc. Thus a novel combination of the drugs which can do Rasagni Deepanaand supplement iron along with prevention of side-effects is the need of the hour. A safe and effective formulation which is also palatable is necessary in children with Iron Deficiency Anaemia,Vidangadi Lauha is one such preparation mentioned for the treatment of Anaemia by Chakradatta which needs to be evaluated for its efficacy in children. Hence the present study is an effort to evaluate the efficacy of “Vidangadi Lauha†in Rasa Pradoshaja Pandu in children W.S.R. to Iron Deficiency Anaemia. |