| CTRI Number |
CTRI/2026/02/103132 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To Test the treatment effect of Ayurvedic medicine Vidangadi Loha Dwitiya with and without Vaman karma (Therapeutic emesis) in Anemia patient |
|
Scientific Title of Study
|
An open label comparative prospective clinical study to evaluate the efficacy of Vidangadi Loha Dwitiya with and without Vaman karma in the management of Pandu with special reference to 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 Jyotiben H Parmar |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul institute of Ayurved And Research Parul University |
| Address |
Department of Kayachikitsa 3rd floor Room no 406 Parul institute of Ayurved And Research Parul University P.O Limda Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7990636801 |
| Fax |
|
| Email |
jyotihparmar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Deshpande |
| Designation |
Professor and Guide |
| Affiliation |
Parul institute of Ayurved And Research Parul University |
| Address |
Department of Kayachikitsa 3rd floor Room no 406 Parul institute of Ayurved And Research Parul University P.O Limda Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9096082950 |
| Fax |
|
| Email |
dr.vaishalid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotiben H Parmar |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul institute of Ayurved And Research Parul University |
| Address |
Department of Kayachikitsa 3rd floor Room no 406 Parul institute of Ayurved And Research Parul University P.O Limda Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7990636801 |
| Fax |
|
| Email |
jyotihparmar2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa 3rd floor Room no 406 Parul institute of Ayurved And Research Parul University P.O Limda Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Jyotiben H Parmar |
| Address |
Department of Kayachikitsa 3rd floor Room no 406 Parul institute of Ayurved And Research Parul University P.O Limda Vadodara Gujarat India 391760 |
| 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 Jyotiben Hamirbhai Parmar |
Khemdas Hospital |
OPD NO 10,Ground Floor, Department of Kayachikitsa, Parul institute of Ayurved And Research Parul University, P.O Limda Vadodara Gujarat India 391760
Vadodara
GUJARAT |
7990636801
jyotihparmar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee IEC - PIAR HR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D539||Nutritional anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidangadi loha Dwitiya, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Vaman Karma | (Procedure Reference: Charak Pandu Chikitsa, Procedure details: Depana Pachan – Aampachak vati 500 mg BD Before Food With Warm water for 3-5 Days,
Snehapan with Go-ghrita upto sneh sidhi lakshna in vardhaman sneha krama,
Abhayanga with Murchit tila tail and Baspa Swedana
Vaman with Madanphal pippali churna according to Rogi bala
Samsarjana krama – Base on Shuddhi.
After that medicine
)
(1) Medicine Name: Vidangadi Loha Dwitiya, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of any gender aged 18–60 years and diagnosed with anemia
2.Hemoglobin level between 8–10.9gm/dl
3.Willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1.Patients with congenital hematological disorders (e.g. SCA, Hemophilia), Leukemia.
2.Patients with uncontrolled bronchial asthma, cardiovascular disease, cerebrovascular disease.
3.Patients with tuberculosis, HIV, or malignancy.
4.Pregnant or lactating women.
5.Known cases of renal dysfunction.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Hemoglobin Levels.
2.Improvement in classical signs and symptoms of Pandu.
3.Improvement in Quality of life through Fatigue Scale. |
1.0th Day and 90th Day
2.0th Day, 30th Day, 60th Day, 90th Day.
3.0th Day, 30th Day, 60th Day, 90th Day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison between Group A (Vidangadi Loha Dwitiya with Vaman Karma) and Group B (Vidangadi Loha Dwitiya without Vaman Karma) in terms of symptom relief.
2.Comparison between Group A (Vidangadi Loha Dwitiya with Vaman Karma) and Group B (Vidangadi Loha Dwitiya without Vaman Karma) in terms of laboratory parameters.
3.Monitoring for adverse events related to the medication.
4.Monitoring for complications related to the Vaman Karma procedure.
|
1.0th Day, 30th Day, 60th Day, 90th Day.
2.0th Day 90th Day
3.0th Day, 30th Day, 60th Day, 90th Day.
4.throughout the procedure period.
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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="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
|
The present study is designed as an open label, comparative, prospective clinical trial to evaluate and compare the efficacy of Vidangadi loha Dwitiya administered with and without Vaman karma in the managment of pandu with special reference to anemia. The study aims to assess improvement in clinical feature of pandu and hematological parameter, thereby generating scientific evidence on the role of Sodhan assisted and Saman based ayurvedic management in pandu. |