| CTRI Number |
CTRI/2025/08/093137 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy of Vajra Vatak Mandoor and Tapyadi Loha Vati in the management of Iron deficiency Anaemia |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate the efficacy of Vajra Vatak Mandoor and Tapyadi Loha Vati in the management of Pandu with special reference to Iron deficiency anaemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Dhanshri Suresh Ambure |
| Designation |
PG Scholar |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR NO 25 NIGADI PUNE |
| Address |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India Pune
MAHARASHTRA
411044
India
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
7620686834 |
| Fax |
|
| Email |
dhanshriambure88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Vrinda Kurande |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune |
| Address |
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India Pune
MAHARASHTRA
411044
India
PDEAs College Of Ayurved And Research Centre Kayachikitsa Department Third Floor Nigdi Pune Maharashtra 411044 India Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
7722030521 |
| Fax |
|
| Email |
vrinda.kurande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vrinda Kurande |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044 |
| Address |
PDEAS College of Ayurved and research centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7722030521 |
| Fax |
|
| Email |
vrinda.kurande@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS College of Ayurved and Research Centre Nigdi Pune MAHARASHTRA 411044 INDIA |
|
|
Primary Sponsor
|
| Name |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE NIGADI PUNE 411044 |
| Address |
PDEAS college of Ayurved and research centre sector 25 Nigdi Pune Maharashtra 411044 India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Vd Dhanshri Suresh Ambure |
Ayurved Rugnalaya And Snowbell Multispeciality Hospital Nigdi Pune |
Ayurved Rugnalaya And Snowbell Multispeciality hospital Sector No 27 Kayachikitsa Department Opd no 117 Nigdi Pradhikaran Pune 411044
Pune MAHARASHTRA
Pune
MAHARASHTRA |
7620686834
dhanshriambure88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAS COLLEGE INSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vajra vatakmandoor, Reference: bhaishajya ratnavali pandukamlahalimak adhikar 50-55, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: BUTTERMILK), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tapyadi loha , Reference: Ashtang hridya 16/20-22, Bharat bhaishajya ratnakar dwitiya khand (2562), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -honey ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Biochemical Parameters -
Hb%:-
Female: 7-10% gm/dl
Male: 7-11% gm/dl
2. Patients having 3 or more symptoms such as
Panduta (Pallor),Akshikoot shoth (Periorbital Oedema), Aayasen Shwas (Dyspnoea on exertion),Dourbalya (Weakness)
, Bhrama (Giddiness) |
|
| ExclusionCriteria |
| Details |
CRITERIA FOR EXCLUSION
1. Known cases of cirrhosis of the liver, ascites, alcoholic liver disease in adults, and children
2. Pregnant and lactating mother.
3. Known case of Uncontrolled Diabetes mellitus
4. Chronic Kidney Disease
5. Known cases of - HIV, Aplastic Anaemia, Pernicious Anaemia, megaloblastic anaemia, Sickle cell anaemia and thallasemia, Sideroblastic Anaemia, leukaemia, Metastasis cancer.
6. Patient receiving care from another physician for the same issue. |
|
|
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 compare the efficacy of Vajra vatak mandoor and Tapyadi loha vati on Objective increasing Hb% given for 60 days in the management of Pandu w.s.r to Iron deficiency anaemia.
|
at day 15,30,45,60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy of Vajra vatak mandoor and Tapyadi loha vati
for reducing symptoms given for 60 days in the management of Pandu w.s.r to Iron deficiency anaemia.
2. To observe and compare the adverse effects in two groups within 60 days. |
at day 15,30,45,60 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
27/08/2025 |
| 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="0"
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
|
In iron deficiency anaemia, symptoms such as pallor, fatigue, weakness, Palpitations and dyspnoea are commonly observed, which resemble the symptoms of Pandu Vyadhi as described by our Acharyas.According to the World Health Organization (WHO), over one-third of the global population suffers from Pandu (anaemia), with India continuing to be among the countries with a very high prevalence rate 15.61
Iron deficiency is a highly common form of malnutrition, responsible for 50% of anaemia cases worldwide. The kalpas selected for study mainly act as kaphaghna, vataghna, raktvardhak, dipana, pachna, krumighna and acts on dhatwagni so helps to break the samprapti (pathogenesis) of pandu
|