| CTRI Number |
CTRI/2026/04/108428 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare Talisadi Tablets and Navayasa Loha Tablets for Increasing Haemoglobin Levels in Pregnant Women with Anaemia.” |
|
Scientific Title of Study
|
An open label double arm randomised clinical study to compare the efficacy of talisadi gutika and navayasa loha in garbhini pandu w.s.r anaemia in pregnancy. |
| 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 Gayathri P M |
| Designation |
Postgraduate scholar |
| Affiliation |
Sri kalabyaraveshwara swamy ayurvedic medical college |
| Address |
Department of Prasootitantra and stree roga room no 209 skamc and rc 10 pipeline road vijayanagar 2nd stage rpc layout vijayanagar bangalore
vijanagar Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9446284664 |
| Fax |
|
| Email |
drgaya3tvrpgskamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Anupama V |
| Designation |
Professor |
| Affiliation |
Sri kalabyaraveshwara swamy ayurvedic medical college |
| Address |
Department of Prasootitantra and stree roga room no 209 skamc and rc 10 pipeline road vijayanagar 2nd stage rpc layout vijayanagar bangalore
vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Anupama V |
| Designation |
Professor |
| Affiliation |
Sri kalabyaraveshwara swamy ayurvedic medical college |
| Address |
Department of Prasootitantra and stree roga room no 209 skamc and rc 10 pipeline road vijayanagar 2nd stage rpc layout vijayanagar bangalore
vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Gayathri P M |
| Address |
Department of PTSR
Room number -209
Sri Kalbyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre Bangalore 10 Pipeline road RPC layout Vijayanagar Bangalore 560104 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gayathri P M |
Sri kalabyraveshwara swamy ayurvedic medical college |
Department of Prasootitantra and Stree roga room number 209 SKAMC and RC 10 pipeline road vijayanagar 2nd stage RPC layout Vijayanagar Bangalore
vijanagar Bengaluru
Bangalore
KARNATAKA |
9446284664
drgaya3tvrpgskamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O990||Anemia complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: navayasa loha, Reference: charaka samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: talisadi gutika, Reference: sharangadhra samhitha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -leukwarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Hb percentage more than 7 and less than 11gm percentage
Patients between age group of 18 to 35 years
Patients of second and third trimesters
Primigravida and multigravida
Patients presenting with any 3 symptoms mentioned in diagnostic criteria with
Hb percentage more than 7 and less than 11gm percentage
|
|
| ExclusionCriteria |
| Details |
Patients of first trimester.
Patients diagnosed with anaemia due to thalassemia, sickle cell anaemia, haemolytic
anaemia, aplastic anaemia,pernicious anemia.
Patients diagnosed with Bleeding piles,Multiple pregnancy,Antepartum haemorrhage.
Patients diagnosed with gestational diabetes, pregnancy induced hypertension which
interfere with the course of treatment. |
|
|
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 |
To asses the reduction in Panduta,Annadwesha,Shrama,Bhrama, Dourbalya and other parameters in two treatment modalities viz talisadi gutika and navayasa loha in Garbhini Pandu wsr to anaemia in pregnancy.
|
1year 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nill |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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="1"
Months="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Anaemia in pregnancy (Garbhini Pandu) is a common and serious health problem, especially in developing countries, occurring due to increased iron requirement and deficiency of iron, folic acid and vitamin B12. It presents with symptoms like weakness, fatigue, giddiness, dyspnoea and pallor. According to Ayurveda, indulgence in nidana of Pandu during pregnancy leads to rakta-mamsa kshaya causing Garbhini Pandu. Classical formulations like Navayasa Loha and Talisadi Gutika are traditionally used in the management of Pandu, and the present study aims to evaluate their efficacy in improving maternal health safely and effectively. |