| CTRI Number |
CTRI/2025/10/096056 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
USE OF TARAMANDUR GUD FOR TREATING PANDU DISEASE (IRON DEFICIENCY ANEMIA) |
|
Scientific Title of Study
|
PHARMACEUTICO-ANALYTICAL STUDY AND CLINICAL EVALUATION OF TARAMANDUR GUD W.S.R. TO PANDU ROGA (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 ANITA KUMARI MEENA |
| Designation |
PG Scholar RSBK |
| Affiliation |
MMM Goverment Ayurveda College Udaipur |
| Address |
Department of rasshastra and bhaishajya kalpana MMM
udaipur
RAJASTHAN
313001
India
Department of rasshastra and bhaishajya kalpana MMM
udaipur
RAJASTHAN
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
7023341714 |
| Fax |
|
| Email |
akmeena428@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AJAY KUMAR SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MMM Goverment Ayurveda College Udaipur |
| Address |
Department of rasshastra and bhaishajya kalpana MMM
udaipur
RAJASTHAN
313001
India
Department of rasshastra and bhaishajya kalpana MMM
udaipur
RAJASTHAN
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413257535 |
| Fax |
|
| Email |
sharmadrajay@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANITA KUMARI MEENA |
| Designation |
PG Scholar RSBK |
| Affiliation |
MMM Goverment Ayurveda College Udaipur |
| Address |
Department of rasshastra and bhaishajya kalpana MMM
udaipur
RAJASTHAN
313001
India
Department of rasshastra and bhaishajya kalpana MMM
udaipur
RAJASTHAN
313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
7023341714 |
| Fax |
|
| Email |
akmeena428@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.M.M. govt. Ayurveda College, Udaipur (Rajasthan) |
|
|
Primary Sponsor
|
| Name |
MMM Goverment Ayurveda College Udaipur |
| Address |
MMM.Goverment Ayurveda College Ambamata Udaipur Rajasthan |
| Type of Sponsor |
Government 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 |
| DR ANITA KUMARI MEENA |
M.M.M. GOVT. AYURVEDA COLLEGE, UDAIPUR |
OPD NO. 2, PG DEPT. OF RAS SHASHTRA AND BHAISHAJYA KALPANA, MMM GOVT. AYU. COLLEGE, UDAIPUR
Udaipur
RAJASTHAN |
7023341714
akmeena428@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM Goverment Ayurveda College Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z679||Unspecified blood type. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TARAMANDUR GUD, Reference: BHAISHAJYA RATNAWALI, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 375(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: LUKEWARM WATER), Additional Information: N/A | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:PLACEBO WITH CONTROLLED DIET , Pathya/Apathya:yes, Pathya:Mudga (green gram), Shashtika Shali (old rice), Amalaki (Indian gooseberry), Draksha (raisins), Dadima (pomegranate), Punarnava, Yava (barley), Tikta Patra Shaka (bitter leafy vegetables), Moola (radish), Patola (pointed gourd), Lauki (bottle gourd), and Triphala., Apathya:Guru Ahara (heavy foods), Dadhi (curd), Amla Rasa Ahara (sour foods), Lavana Rasa Ahara (salty foods), Katu Rasa Ahara (pungent foods), Mamsa (meat), Madya (alcohol), Navanna (newly harvested grains), Ksheera (milk in excess), Tila (sesame), Guda (jaggery), and Atyushna Ahara (very hot foods). |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Sign and symptoms of Anaemia.
Evidence of Anaemia by lab investigations.
Participates in age group of 18-70 years.
Patients with Anaemia between 06gm percent-10gm percent of Haemoglobin |
|
| ExclusionCriteria |
| Details |
Patients suffered with serious cardiac disorders like Mi, Cardiac failure and Crisis
Patients having life threatening disease.
Patient having major illness like IDDM, DM which is poorly controlled or newly diagnosed or is taking new therapy or recently adjusted
therapy.
Patient having Carcinoma, Pregnant lady.
Patient with severe Anaemia below 06 gm% of Haemoglobin.
Patient suffering with Thalassemia, Bone marrow disorders.
Autoimmune disorders and Iron toxicity.
Patient himself or hersell wants to withdraw from the clinical trial |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in quantity of haemoglobin. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| anemia scale will be assessed |
15 days, 30 days, and 45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/01/2026 |
| 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="0"
Months="2"
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
|
This study is A Comparative Pharmaceutico Analytical Study And Clinical Evaluation of Taramandur Gud W.S.R. To Pandu Roga (Iron deficiency Anaemia). There will be 2 groups in the study, in Group A randomly selected and clinically diagnosed 30 patients of Pandu roga whose Hb gm % will be of 06 to 10 gm %. Group A will be given Taramandur Gud prepared as per classical method and 30 patients of Group B randomly selected and clinically diagnosed will be given placebo with controlled diet.
Trial will be conduct for a period of 2 months. Follow up of the case will be after every 15 days that is 4 times during treatment. Final assessment will be done after completion of 2 months course on the basis of subjective, objective and laboratory assessment.
The data will be analyzed scientifically and statistically. |