| CTRI Number |
CTRI/2025/06/089684 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two group clinical study to know the effect of Amalaki fortified biscuits as a nutritional suppliment in adolescents with iron deficiency anaemia |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effectiveness of Amalaki fortified biscuits as a nutritional suppliment in adolescents with iron deficiency anaemia |
| 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 Manjula Heggai |
| Designation |
Part time PhD Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
| Address |
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, B M Road Tanniruhalla Hassan 573201
Karnataka
Assistant Professor
Department of Swasthavritta
SBSS Krishna Ayurvedic Medical College and Hospital Sankeshwar
Hassan
KARNATAKA
573201
India |
| Phone |
8722729458 |
| Fax |
|
| Email |
manjulabhashini.heggai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita MB |
| Designation |
HOD and Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
| Address |
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, B M Road Tanniruhalla Hassan 573201
Karnataka
HOD and Professor
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, B M Road Tanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9986432954 |
| Fax |
|
| Email |
drmbkavita@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula Heggai |
| Designation |
Part time PhD Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan |
| Address |
Department of Swasthavritta
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, B M Road Tanniruhalla Hassan 573201
Karnataka
Assistant Professor
Department of Swasthavritta
SBSS Krishna Ayurvedic Medical College and Hospital Sankeshwar
Hassan
KARNATAKA
573201
India |
| Phone |
8722729458 |
| Fax |
|
| Email |
manjulabhashini.heggai@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manjula Heggai |
| Address |
Assistant professor
Department of Swasthavritha
SBSS Krishna Ayurvedic Medical College and Hospital Sankeshwar 591313 |
| Type of Sponsor |
Other [self funding] |
|
|
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 Manjunath Gavimath |
SBSS Krishna Ayurvedic Medical College and Hospital Sankeshwar |
Physiology and Swasthavritha department, clinical laboratory
room no-7,8
Belgaum
KARNATAKA |
9008312978
-
kamchsnk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| SBSS Krishna Ayurvddic Medical college and Hospital |
No Objection Certificate |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E638||Other specified nutritional deficiencies. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: amalaki fortified biscuit, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 40(g), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -jala), Additional Information: -nil | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: punarnava mandura, Reference: Charaka Samhita , Chikitsa Sthana, chapter16, shloka 93-95, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -jala), Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1.Mild to Moderate Iron deficiency anaemia(7-11.9gm% of Hb),Reduced RBC, Reduced Haematocrit and reduced serum iron, reduced ferritin and raised TIBC.
2.Volunteers irrespective of gender, place, climate and religion
3.Volunteers whose parents/themselves(as per age)are ready to give written consent |
|
| ExclusionCriteria |
| Details |
1.Known case of Hemolytic anaemia,Aplastic anaemia, Pernicios Anaemia, Thalassemia and Sickle cell anaemia.
2.Known case of severe and life threatening anaemia.
3.Known case of chronic disease anaemia. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Amalaki fortified biscuits as a nutritional supplement in iron deficiency anaemia |
Total duration 90days
assessment willbe before treatment,on 30th day,on 60th day and on 90th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nutritional analysis of amalaki fortified biscuits in terms of micronutrients and macronutrients in context of iron deficiency |
three years |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/01/2026 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
It is a comparative clinical trial. Total number of sample is 100 . With alternate allocation samples are grouped into two groups. Group A with 50 samples will be screened for iron deficiency anaemia and given Amalaki fortified biscuits for 90 days. two biscuits weighing 20grams each will be given afternoon in the empty stomach after confirming the dewormin treatment within 6 months. Group B with 50 samples will be screened for iron deficiency anaemia and given control drug punarnava mandura for 90 days Two tablets of 500mg each will be given in the afternoon empty stomach. The volunteers will be assessed for subjective and objective parameters. The symptoms will be assessed before intervention, on 30th day, 60th day and after completion of intervention. The biochemical parameters will be assessed before and after completion of intervention.Assessment will be done based on grading and improvements/changes in subjective as well as objective parameters before during and after treatment. Panduta, Hatanala Dourbalya, Shrama,
Aarohanaayasa, Bhrama, Hrudrava, Karnakshweda, Aruchi, Agnimandyam,
Shirnalomata, Pindikodweshtanam, Tama darshana, Hridayaspandanadhikya will be evaluated for their presence. Hb%, serum iron, Serum ferritin and TIBC (if
possible in randomly few cases) will be assessed pre and post intervention. Frequency tables and
crosstabs would be generated for all the variables considered. Association with
demographic and exposure variables would be worked out using the chi-square test.
If the variable is a scale variable paired t-test, ANOVA, student’s t-test, and
repeated measures ANOVA would be used to test the effect of the intervention.
If in case the variable is ordinal nominal, the Wilcoxon sign rank test,
Friedman and Mann-Whitney U test would be used. Advanced statistics tests
would be conducted based on the data availability.
|