| CTRI Number |
CTRI/2025/10/096327 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| 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
|
An Ayurvedic Approach to Pandu Roga (Iron Deficiency Anaemia) through Mandurvatak and Panchtiktghrit Matra Basti |
|
Scientific Title of Study
|
To Assess the Efficacy of Mandurvatak and Panchtiktghrit Matra Basti in Pandu with special reference to Iron Deficiency Anaemia An Open Randomized clinical controlled Trial |
| 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 Nisha Rathod |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. |
| Address |
OPD No. 08. Ground Floor Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8104841255 |
| Fax |
|
| Email |
nisharathod074@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minal S Vaidya |
| Designation |
Professor and HOD |
| Affiliation |
Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. |
| Address |
OPD No. 08. Ground Floor Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9323790371 |
| Fax |
|
| Email |
drminalsvaidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Minal S Vaidya |
| Designation |
Professor and HOD |
| Affiliation |
Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. |
| Address |
OPD No. 08. Ground Floor Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9323790371 |
| Fax |
|
| Email |
drminalsvaidya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.G.D.Pol Foundation,YMT Ayurvedic Medical College and Hospital kharghar navi mumbai 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Nisha Rathod |
| Address |
OPD No. 08. Ground Floor Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India |
| 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 Nisha Rathod |
Dr. G. D. Pol Foundation, YMT Ayurvedic Medical College and Hospital |
OPD No. 08. Ground Floor Kayachikitsa Department, Dr. G. D.Pol Foundation, YMT Ayurvedic Medical College. Institutional Area, Sector 4 Kharghar.Navi Mumbai Raigarh MAHARASHTRA 410210 India
Raigarh
MAHARASHTRA |
8104841255
nisharathod074@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr.G D Pol Foundation, YMT Ayurvedic medical college and charitable hospital |
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 | Comparator Arm (Non Ayurveda) | | - | FERROUS SULPHATE | Dose-200 mg OD daily Duration-3 months Route-Oral | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mandurvatak, Reference: Charak Chikitsa 16 Pandurogadhyay, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: -(2) Medicine Name: PANCHTIKTGHRIT, Reference: Sharangdhar Samhita Madhyamkhand Adhyay 9, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Will be used as combined therapy:Mandurvatak with PANCHTIKTGHRIT. PANCHTIKTGHRIT Matra basti will be given 11 days in each month for consecutive 3 months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Hb between 7 to 11.5 mg/dl in female and 7 to 13.5 mg/dl in male.
Sr.Ferritin less than 15 ng/ml in female and
less than 30 ng/dl in male.
Sr.iron less than 50 ug/L
TIBC greater than 250 ug/L
Pt who withdraw from oral or parental iron therapy. |
|
| ExclusionCriteria |
| Details |
K/C/O Thalassemia/Aplastic Anaemia/sickle cell Anaemia/Megaloblastic Anaemia.
K/C/O any haemorrhagic disorder i.e. active bleeding.
K/C/O any systemic disorder i.e.cardiac/ renal/ hepatic/endocrine disorders.
K/C/O Immune compromised patients or subjects of Immune suppressive drug.
Helminthic infestation(H/o presence of helminithic in stool routine examination)
Pregnancy and Lactation.
Acute life threatening condition. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the changes in haemoglobin level by Mandurvatak alone or in combination with panchtiktghrit matra basti in comparison with Ferrous Sulphate. |
Assessment on 0th 30th 60th 90th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor and compare the gastrointestinal side effects of all three groups. |
Assessment on 0th 30th 60th 90th days. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/11/2025 |
| 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 Yet Recruiting |
| 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
|
The primary purpose of this study is to evaluate and compare the efficacy of Mandurvatak an Ayurvedic herbo-mineral formulation alone and in combination with Panchtiktghrit Matra Basti in the management of Pandu Roga (Iron Deficiency Anaemia). The study aims to assess improvements in haemoglobin levels, iron indices, and clinical symptoms while also monitoring any gastrointestinal side effects in comparison with conventional therapy.
This open randomized controlled clinical trial includes three groups:
-
Group A (Control Group): Ferrous Sulphate 200 mg daily.
-
Group B (Trial Group 1): Mandurvatak ½ Karsha daily orally.
-
Group C (Trial Group 2): Mandurvatak ½ Karsha daily orally combined with Panchtiktghrit Matra Basti (60 ml for 11 days in each month).
Each group will be treated for three months with regular monthly follow-ups to evaluate both clinical and haematological outcomes.
Study Hypothesis:
Mandurvatak alone or in combination with Panchtiktghrit Matra Basti significantly improves haemoglobin concentration and iron metabolism in patients with Pandu (Iron Deficiency Anaemia) compared to conventional Ferrous Sulphate therapy. |