| CTRI Number |
CTRI/2025/07/090275 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the effect of navayas lauh in the patient of anemia through raktdhatwagni parameter. |
|
Scientific Title of Study
|
Physiological study on raktdhatvagni in pandu rog with the intervention of navayaslauha. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ProfDr Srikanta Kumar Panda |
| Designation |
Professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and Hospital |
| Address |
Department of Kriya Sharira Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9871553996 |
| Fax |
|
| Email |
drspanda79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr Srikanta Kumar Panda |
| Designation |
Professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and Hospital |
| Address |
Department of Kriya Sharira Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9871553996 |
| Fax |
|
| Email |
drspanda79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr Srikanta Kumar Panda |
| Designation |
Professor |
| Affiliation |
Ayurvedic and Unani Tibbia college and Hospital |
| Address |
Department of Kriya Sharira Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9871553996 |
| Fax |
|
| Email |
drspanda79@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani tibbia college and Hospital, Karol Bagh, Delhi - 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia college and Hospital |
| Address |
Ayurvedic and Unani Tibbia college and Hospital Karol Bagh Delhi - 110005 |
| 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 Mohit kumar |
Ayurvedic and Unani tibbia college |
Department of Kriya Sharira, Physiology lab Ground floor Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005
Central
DELHI
Central
DELHI |
7838215612
Kumarmohit5612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: Navas lauha, Reference: Charak chikitsa Sthan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Jal-), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. The presence of symptoms of Pandu as described in classical Ayurvedic texts such as Panduta (pallor), Daurbalya (weakness), Shirahshoola (headache), Shrama (fatigue),and Gaurava
(heaviness)Age between 20 to 50 years.
2. Hb% 10-11 % ( mild anemia) as per WHO.
3. Age between 20 to 50 years. |
|
| ExclusionCriteria |
| Details |
1.Patients below 10 % Hb.
2.Patients suffering from hematological disorders such as sickle-cell anemia
and thalassemia were excluded.
3. Patients suffering from severe systemic disorders such as uncontrolled
hypertension, uncontrolled diabetes mellitus, AIDS, and cancer.
• Pregnant female and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| proportion of participants with 15 % improvement in Hb. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Raktdhatvagni will be assessed through Raktdhatwagni parameter. |
60 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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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 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 cases of Anaemia is increasing day by day through out the world irrespective of gender & age . therefore it becomes our moral duty to find out the relation between anaemia and raktdhatvagni to find better and permanent cure of the disease. Through this study we can establish the relation of raktdhatvagni and blood related disorders more precisely which help us to understand the underlying pathogenesis and treatment better. Therefore, “Physiological Study On Raktdhatvagni In Pandu Rog With The Intervention Of Navayas Lauha”.Is selected as research topic
|