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CTRI Number  CTRI/2026/01/100567 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
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   The effect of dhatri avaleha on iron deficiency anemia among adolescents girls 
Scientific Title of Study   A Randomized controlled clinical study to evaluate the Haematinic effect Of Dhatri Avaleha over Ferrous Sulphate in IDA among Adolescent Girls. 
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 Vaishnavi Sadanand Pawale 
Designation  PG Scholar  
Affiliation  Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal. 
Address  OPD No- 13, Department of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal.

Koppal
KARNATAKA
583231
India 
Phone  8975801362  
Fax    
Email  vash.pawale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suryanarayan Mudadla 
Designation  Head of department 
Affiliation  Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal. 
Address  OPD No- 13, Department of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal.

Koppal
KARNATAKA
583231
India 
Phone  7411642191  
Fax    
Email  surya83.m@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Radhika Injamuri 
Designation  Associate professor and Guide 
Affiliation  Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal. 
Address  OPD No- 13, Department of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal.

Koppal
KARNATAKA
583231
India 
Phone  9108304745  
Fax    
Email  radhikainjamuri.17@gmail.com  
 
Source of Monetary or Material Support  
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College, Koppal, Karnataka, India, 583231. 
 
Primary Sponsor  
Name  Dr Vaishnavi Pawale 
Address  OPD no-13, Department of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College, Koppal. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishnavi Sadanand Pawale  Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College, Koppal.  OPD No- 13, Department of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic College, Koppal.
Koppal
KARNATAKA 
8975801362

vash.pawale@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethical Committee, SJGAMC&H Koppal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Dhatri Avaleha, Reference: charak chikitsa sthana pandu roga adhyaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: mik), Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab ferrous sulphate3-6 mg/kg/day in two divided doses after meals along with water for 90 days. 1 elemental iron tablet is of 60 mg so for example for 20 kg child doses will be 1-2 tablet two times day.
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Female 
Details  1. Adolescent girls belonging to age group between 10-18 years with classical signs and symptoms of Panda roga, irrespective of caste and religion will be included in the study.
2.Adolescent girls having hemoglobin percentage between below 12gms to above 8 gm. /dl. With microcytic hypochromic anemia will be included.
 
 
ExclusionCriteria 
Details  1.Adolescent girls with severe anaemia (below 8 g/dl) and mild-moderate anaemia associated with other systemic disorders like TB, HIV, Cancer, etc.
2.Haemolytic disorders like Thalassemia, Sideroblastic anaemia.
3.Other known cases haemorrhagic diathesis like Haemophilia, ITP, Vit K deficiency etc.
4.Patients on any other medications or health supplements since 4 weeks. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Dhatri Avaleha is significantly more effective than Ferrous Sulphate on Haematinic effect in the management of Iron deficiency anaemia among adolescent girls   120 days 
 
Secondary Outcome  
Outcome  TimePoints 
Boost immunity, improve digestion and strength, improves mental health.  120 days 
 
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   Phase 3 
Date of First Enrollment (India)   20/01/2026 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Iron Deficiency Anaemia (IDA) is considered as one among the top 10 risks globally and regionally contributing to the 14th leading cause of disease burden in the world. IDA is characterized by a defect in haemoglobin synthesis, resulting in hypochromic and microcytic red blood cells. According WHO a person is said to be anaemic when the haemoglobin concentration is less than 12.0 gm/dl. So its deficiency due to either physiological or pathological reason can affect mental and physical growth resulting in decreased learning capacity and work productivity. In absolute numbers anaemia affects 1.62 billion people globally. Although IDA occurs at all age and involves both the sexes, adolescent girls are more prone to it. There are many reasons of IDA in adolescent girls such as deficient intake or absorption of iron, increased demand during adolescence, heavy blood loss during menstruation and parasitic infestation. The requirement for iron in fact doubles during adolescence as compared to younger age. There is a significant increase in the requirement of iron from pre-adolescent level of approximately 0.7 to 0.9 mg iron per day to 1.40 to 3.27 in adolescent girls. Due to high prevalence of anaemia (Haemoglobin less than12 gm. percentage) among adolescent girls in India, causes 1.8 percentage loss of GDP. Therefore, the burden of anaemia is disproportionately higher in women as compared to men.

According to a study by WHO on anaemia during 1993 to 2005, worldwide prevalence of anaemia was 25 percentage. The prevalence of anaemia among adolescent women in India increased from 54.2 percentage (99 percentage CI 53.6 to 54.8) to 58.9 percentage (99 percentage CI 58.3 to 59.5) over the study period (2015 to 16 to 2019 to 21). Among the 28 Indian states, 21 reported an increase in the prevalence of anaemia. The National Family Health Survey 3 (NFHS 3) data suggests that the prevalence of anaemia in adolescent girls (15 to 19 years) is 56 percentage. According to National Nutrition Monitoring Bureau Survey (NNMBS) 2006, the prevalence of anaemia in adolescent girls (12-14 years) is 68.6 percentage whereas in (15 to 17 years) it is 69.7 percentage. The highest prevalence is between the ages of 12 and 15 years when the requirements of iron are at peak. More than 50 percentage girls in this age group have been reported to be anaemic. Due to the rise in anaemia prevalence among adolescent girls in India it suggests the need for targeted interventions to mitigate the burden of anaemia and enhance the overall health of this population. Main line of treatment according to modern science is considered to be use of Iron supplements (Iron drops or pills). Iron supplements such as ferrous sulphate, ferrous fumerate, ferrous succinate etc. are used in day to day practice but it has various side effects which are frequently encountered such as irritation in the gastrointestinal system, constipation, nausea, vomiting and epigastric pain etc. 

In Ayurveda Iron Deficiency Anaemia (IDA) can be clinically compared with Kaphaj pandu roga, because of the predominance of panduta or pallor in the whole body. According to Ayurveda classics it is considered as a santarpanotha vikara. Pandu roga requires treatment such as snehana, tikshna vamana virechana and use of shaman aushadhis. Shaman aushadhis possessing katu-tikta-usna-guna properties are needed. As per this Datri Avaleha mentioned in charaka samhita pandu chikitsa adhyay is said to be having ingredients like amalaki, vanshlochan, draksha, shunthi, yasthimadhu, pippali which contains iron constituents in some ingredients along with that they are balya, pachak, rasayana, GIT stimulant, hepatoprotective, and antioxidant. Though there are many louha formulations mentioned in Ayurvedic classics but due to their non-acceptance and assumed complications from modern system of researches they are usually not preferred by the consumers. So to find out safe and effective herbal medicines that can manage adolescent IDA without any side effects the present study has been chosen to find the Haematinic effect of an Ayurvedic herbal compound named Dhatri Avaleha over Ferrous Sulphate among adolescent girls belonging to 10 to 18 years of age.

 

 
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