| CTRI Number |
CTRI/2023/09/057763 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Herbo-mineral tablet in Iron deficiency anemia in children of 6 to 14 years |
|
Scientific Title of Study
|
A randomized standard control clinical study to evaluate the efficacy of Mandura Vajra Vataka versus oral iron supplementation in Iron deficiency anemia Vis-A-Vis Pandu Roga in children. |
| 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 Gore Snehal Pandurang |
| Designation |
PG scholar,Department of PG studies in Kaumarabhritya |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
OPD No 11, Kaumarabhritya OPD, Department of PG Studies in Kaumarabhritya,Jagdguru Sri shivarathreeshwara Ayurveda Medical College,Lalithadripura road,Alanahalli.
Mysore
KARNATAKA
570028
India |
| Phone |
7219183611 |
| Fax |
|
| Email |
snehalgoreayu75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srihari S |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
OPD No 11, Kaumarabhritya OPD, Department of PG Studies in Kaumarabhritya, Jagdguru Sri shivarathreeshwara Ayurveda Medical College,Lalithadripura road,Alanahalli,
Mysore
KARNATAKA
570028
India |
| Phone |
7776077626 |
| Fax |
|
| Email |
dr.srihari@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srihari S |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
OPD No 11, Kaumarabhritya OPD, Department of PG Studies in Kaumarabhritya,Jagdguru Sri shivarathreeshwara Ayurveda Medical College, Lalithadripura road,Alanahalli
Mysore
KARNATAKA
570028
India |
| Phone |
7776077626 |
| Fax |
|
| Email |
dr.srihari@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Jagdguru Sri Shivratreshwara Ayurveda Medical College & Hospital, Mysuru, Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Gore Snehal Pandurang |
JSS Ayurveda Medical College & Hospital,Lalithadripura road, Alanahalli,Mysuru, Karnataka |
OPD No 11 and IPD, Department of PG Studies in Kaumarabhritya
Mysore
KARNATAKA |
7219183611
snehalgoreayu75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical College Ethical Clerance Committee - Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mandura Vajra Vataka , Reference: Chakradatta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4.5(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Takra ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Oral iron suplementation | Oral iron supplementation with 3 mg/kg of elemental iron will be given once in a day on empty stomach or between the meals with warm water for the duration of 8 weeks. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between the age group of 6 to 14 years irrespective of the gender, caste & socioeconomic status
2.Children having Hb % of 7-10.9 gm%
3.Children presenting with clinical signs and symptoms of Pandu roga and Iron deficiency
anemia
4.Peripheral smear showing hypochromic, microcytic anemia
5.Parents /guardians ready to sign informed written consent.
|
|
| ExclusionCriteria |
| Details |
1.Other known types of anemia like sickle cell anemia, megaloblatic anemia.
2.Other diagnosed severe systemic illness like Severe Acute Malnutrition (SAM), Cerebral
palsy, obesity.
3.Known case of Hemorrhagic diathesis like hemophilia, ITP, Vitamin K deficiency.
4.Known case of hereditary disorder like Thalassemia, Sideroblastic anemia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. comparative reduction in the clinical signs & symptoms of Pandu Roga & IDA at the end of 8 weeks
2.comparative changes in the values of Hb %, Peripheral smear, serum ferritin & TIBC at the end of 8 weeks |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/09/2023 |
| Date of Study Completion (India) |
31/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Nutritional deficiencies are primarily caused by inadequate dietary intake, increased nutrient loss, impaired absorption, and altered nutrient metabolism. When the concentration of hematopoietic nutrients like iron involved in RBC production or maintenance becomes insufficient to meet the body’s needs, nutritional anemia occur. Majority of anemia exists in the form of Iron deficiency anemia (IDA) associated with poor cognitive, physical growth and motor development which affects the school performance in children. Infants, preschool children and adolescents are at greater risk of developing iron deficiency. According to The Fifth National Family Health Survey the prevalence of anemia in 6 to 59 months age group children is 67.1% (Rural -68.3%, Urban – 64.2%) in India and in Karnataka it is 65.5% while that in Mysore and Chamarajanagara district it is 27.6% .The prevalence of anemia is significant in India because the majority of IDA patients come from lower-or middle-class families, particularly in areas where nutrient deficits i.e. diet is predominantly carbohydrate (wheat, rice) based and vegetarian. Worm infestations and infection are frequently encountered in such population too. Clinical manifestations of IDA include pallor, fatigue, dizziness, reduced exercise capacity, irritability, pica and adverse effects on neurodevelopment, growth and immunity. The nearest correlation of Iron deficiency anemia in Ayurveda can be made with Pandu Roga, because of the predominance of Panduta or pallor in the whole body. Pandu is a Pitta Pradhana and Rasa-Raktapradoshaja Vyadhi manifested in five types as per predominance of Dosha.Samanya Lakshana of Pandu as per Kashyapa Samhita are, Nabhyam Samantat Shotha (swelling around umbilicus), Shwetakshi (pallor of eyes), Nakhavakrata (deformity of nails), Agnisada, Nashtagni (loss or reduced digestive capacity), Akshikuta Shotha (Periorbital edema) and Rudhiraspruha (desires for blood as in pica).Line of treatment in Pandu Roga is Samshodhana, Samshamana and Pathya palana. In the contemporary system of medicine, oral iron supplementation is recommended in children suspected with iron deficiency anemia. Ferrous sulphate continues to be the gold standard and the preparation of choice. Acceptable alternatives include ferrous fumarate, gluconate, or ascorbate.Although effective, poor drug compliance stands as a hurdle in continuation of modern treatment. As adverse reactions, gastrointestinal symptoms like nausea, vomiting, abdominal pain, constipation, black feces and diarrhea are also reported frequently. Mandura Vajra Vataka is the drug selected for the present clinical study which has been mentioned in the treatment of Pandu in Chakradatta.It contains herbal drugs which act as Agni Deepana and Pachana due to their hot potency enhances digestion and natural absorption of Iron, Vidanga acts as Krimighna and Musta, Devdaru does Raktaprasadana. Mandura helps in restoring Iron in the body which helps in the management of Pandu roga. Thus, the trial drug concentrates on proper functioning of Agni which is very important for digestion, absorption and assimilation of nutrients to meet the demand of body, and also there is supplementation of Iron (Mandura) in the deficiency state. Hence based upon above references the following study has been designed to understand the role of Mandura Vajra Vataka in Pandu Roga |