| 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 |
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Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
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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. |
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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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
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| Dept of Stree roga Avum Prasuti tantra SSTAC Sangamner,ahamadnagar (MH) 422605,India. |
|
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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] |
|
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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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 |
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics commiteeSSTAC |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | Classical | | (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: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
| Intervention |
Nil |
Nil |
|
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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
|
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| 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 .
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Alternation |
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Blinding/Masking
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Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Increase Hemoglobin % in 8 weeks |
Increase Hemoglobin % in 8 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease breathlessness, palpitation, fatigue |
In 8 weeks with oral grug |
|
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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" |
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Phase of Trial
|
Phase 2/ Phase 3 |
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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 |
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Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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” | | |