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CTRI Number  CTRI/2025/10/095858 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   RANDOMIZED CONTROLLED CLINICAL TRIAL TO DETERMINED THE EFFECT OF DARVYADI CHURNA WITH MADHUchurna IN THE MANAGEMENT OF GARBHINI PANDU W.S.R TO IRON DEFECIENCY OF ANEMIA. 
Scientific Title of Study   Randomized controlled clinical trial to determined the effect of darvyadi churna with madhu in the managment of garbhini pandu W.S.R. to iron deficiency anemia .  
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 Suprriya Karkhilay 
Designation  PG scholar 
Affiliation  SST Ayurveda mahavidyalay Sangamner 
Address  Department of stree roga avum prasuti tantra SSTAC Sangamner

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  9850147511  
Fax    
Email  temgiresupriya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Shinde 
Designation  HOD dept stree rog Avum Prasuti tantra  
Affiliation  SST Ayurveda mahavidyalay Sangamner 
Address  Department of stree roga avum prasuti tantra SSTAC Sangamner

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  9881303593  
Fax    
Email  amitShinde112@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suprriya Karkhilay 
Designation  PG scholar 
Affiliation  SST Ayurveda mahavidyalay Sangamner 
Address  Department of stree roga avum prasuti tantra SSTAC Sangamner

Ahmadnagar
MAHARASHTRA
422605
India 
Phone  9850147511  
Fax    
Email  temgiresupriya@gmail.com  
 
Source of Monetary or Material Support  
Dept of Stree roga Avum Prasuti tantra SSTAC Sangamner,ahamadnagar (MH) 422605,India. 
 
Primary Sponsor  
Name  Dr.Suprriya Karkhilay 
Address  Dept.of stree roga avum prasuti tantra SSTAC Sangamner Ahmadnagar(MH)422605,India. 
Type of Sponsor  Other [Own research study] 
 
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 
Suprriya Karkhilay  Sangam sevabhavi Ayurved Mahavidyalay ,Sangamner  OPD division 1st Floor room no 1 Stree roga Avum Prasuti tantra OPD
Ahmadnagar
MAHARASHTRA 
9850147511

temgiresupriya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics commiteeSSTAC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Drvyadi churna with Madhu, Reference: charak chikistasthan , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)DrugClassical(1) Medicine Name: ferrous sulphate, Reference: D.C.Datta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 200(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -water), Additional Information: -
3Comparator Arm (Non Ayurveda)Drug-
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Pregnant women, belonging to the age group of 21 to 35 years having clinical signs and symptoms of Garbhini Pandu, i.e., Panduta (pallor), Bhrama (giddiness), Daurbalya (general weakness), Shwasa (dyspnea),Akshikutshotha
2. Pregnant women of 2nd trimester and 7th month of 3rd trimester of pregnant women.
3. Pregnant women of second or third trimester of pregnancy with 7 g% to 10 .9 g% of hemoglobin
4. Microcytic hypochromic appearance of red blood cells in peripheral smear.
5. Pregnant women who give concent for study
 
 
ExclusionCriteria 
Details  1. Pregnant women suffering from pregnancy-related complications such as pregnancy-induced hypertension, hyper emesis gravidarum, pre eclampsia, etc.
2. Pregnant women with high-risk pregnancy
3. Pregnant women having severe anemia .
4. Bleeding Disorders like Haematemesis, Malena, bleeding hemorrhage etc .
 
 
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 
Increase Hemoglobin % in 8 weeks  Increase Hemoglobin % in 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease breathlessness, palpitation, fatigue  In 8 weeks with oral grug  
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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/ Phase 3 
Date of First Enrollment (India)   21/10/2025 
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="0" 
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 which is most prevalent nutritional deficiency disease in both the developed and developing countries with its prevalence rate higher in children and women of child bearing age. Globally, 30% of the total world population are anaemic and half of these have Iron Deficiency Anaemia. According to WHO, 50% of children and women and 25% of men in developing countries like India are suffering from Iron Deficiency Anaemia.1

                          The disease Pandu has been vividly and quite in detail described in Ayurveda. There are no direct references of Garbhini Pandu (anemia in pregnancy) in Ayurveda, except Acharya Kashyapa has described Pandu as a symptom of Garbhini in the description of Rakta Gulma,2 Acharya Harita has also described Vivarnatva as one of the eight complications of Garbha.3 Pandu Vyadhi is considered as pitta pradhan. The vitiating factors of pitta can also be taken as a cause of Pandu Vyadhi. Based on the clinical features of Pandu Roga, such as Alpa Rakto (poor quality and reduced quantity of blood tissue), Swetakshi (pallor of palpebral conjunctiva), Akshikoot Shotha (periorbital edema), Nashtagni (impaired metabolism), and Nirutsah (fatigue).4 .5 Pandu Vyadhi is a disease characterized by pallor of body which resembles with ‘Anemia’ of modern science. Rakta has been considered as a key factor for the Jeevana, Preenana, dharana, and Poshana Karma of the body.6 Many times it is seen that Rakta gets vitiated by doshas, mainly by pitta dosha as Rakta and pitta share an Ashrayashrayi bhava, leading to Pandu Vyadhi.7

Considering Panduta (pallor) as the predominant sign, the disease is termed as Pandu Roga. The nearest correlation of iron deficiency Anemia (IDA) can be made with Pandu Roga, because of the predominance of Panduta or pallor in the whole body. 

In modern medicine for the treatment and prevention of iron deficiency Anemia, Ferrous sulphate is used when the amount of iron taken from the diet is not adequate.9 Ayurveda can provide better management in this area. The need for discussion of Pandu becomes important because it is the commonest nutritional disorder all over the world and major problems of mankind especially in countries like India due to low economic status, illiteracy, malnutrition in a part of the population.10

Need of Study

Iron-deficiency Anemia (IDA) is the most common nutritional deficiency in the world. It manifests as a hypochromic microcytic Anemia with low blood indices and serum ferritin. IDA is the most common form of Anemia in the women of reproductive age group and is frequently seen among pregnant women in developing countries with a prevalence of 35-75 per cent.11 In India, the prevalence of Anemia among pregnant women is about 65-75 per cent12. Anemia has a significant impact on the health of the mother as well as that of the foetus. It leads to preterm delivery, intrauterine growth retardation, low birth weight, postpartum haemorrhage, cardiac failure and increased risk of infections.13 Females of lower socioeconomic status  have a lower odds of anaemia screening in pregnancy compared with higher socioeconomic status counterparts.14

In Ayurveda Pandu Chikitsa Darvyadi Churna with Madhu is mentioned by Acharya Charaka in Pandu Chikitsa.15 Darvyadi yoga contains 9 ingredients. One of its ingredients is Ayoraj (Lauha Bhasma) which makes formulation ideal indication for the treatment of Pandu Roga. it also contain Triphala and Trikatu have role in the maintenance of digestive fire (Jatharagni).16 moreover amlaki contains ascorbic acid which facilitates iron absorption by forming a chelate with ferric iron at acid pH that remains soluble at the alkaline pH of the duodenum.17 Vidanga has Krimihara properties and worm infestation is usually seen in children suffering from Pandu Roga. All the drugs are easily available in market and cost effective solution to treat Pandu. Ferrous sulphate is proven modern drug18 hence it has taken as control group.The purpose of the clinical trial is primarily to establish the efficacy of this drug as it is easy to take and having no side effects. So this study is an attempt to find a better solution for the treatment of Pandu with special reference to Iron deficiency Anemia in pregnant women. Hence study has been planned as “ Randomised controlled clinical study to determine the effect of Darvyadi Churna with Madhu in the management of   Garbhini Pandu W.S.R. to Iron deficiency Anemia”

 
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