| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab ferrous sulphate | 3-6 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. |