| CTRI Number |
CTRI/2025/06/088221 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| 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
|
A research study to see if adding a herbal mix (Dahanadi Churna and Dhatri Loha) helps in treating anemia better, using a fair comparison method |
|
Scientific Title of Study
|
Randomized controlled clinical trial of add on effect of dahanadi churna with dhatri loha in management of pandu roga |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VdArshiya jahangir ansari |
| Designation |
PG scholar |
| Affiliation |
Tilak ayurved mahavidyalaya and seth Tarachand hospital |
| Address |
Tilak ayurved mahavidyalaya, department of kayachikitsa,1 st floor 583/2,rasta peth,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7972705732 |
| Fax |
|
| Email |
arshiyaansari2908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vdsangeeta s ghodake |
| Designation |
Associate professor, kayachikitsa department |
| Affiliation |
Tilak ayurved mahavidyalaya and seth Tarachand |
| Address |
Tilak ayurved mahavidyalaya, department of kayachikitsa,1 st floor 583/2,rasta peth,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7972705732 |
| Fax |
|
| Email |
sangita.ghodke@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
VdArshiya jahangir ansari |
| Designation |
PG scholar |
| Affiliation |
Tilak ayurved mahavidyalaya and seth Tarachand |
| Address |
Tilak ayurved mahavidyalaya, department of kayachikitsa,1 st floor 583/2,rasta peth,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
7972705732 |
| Fax |
|
| Email |
arshiyaansari2908@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak ayurved mahavidyalaya pune |
|
|
Primary Sponsor
|
| Name |
Tilak ayurved mahavidyalaya |
| Address |
Tilak ayurved mahavidyalaya,rasta peth,pune 411011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| VdArshiya jahangir ansari |
Seth Tarachand ramnath charitable ayurved hospital |
Tilak Ayurved Mahavidyalaya, Department of Kayachikitsa, OPD no. 5, Ground floor, Rasta peth, Pune-411011 MAHARASHTRA
Pune
MAHARASHTRA |
07972705732
arshiyaansari2908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee TAMV PUNE |
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 | Drug | Classical | | (1) Medicine Name: Dhatri loha, Reference: Bhaishajya ratnavali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dahanadi churna , Reference: Vangasen sanhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Amlatakra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
1.The presence of symptoms of Pandu as described in classical Ayurvedic texts such as Panduta, Dourbalya, Shirshoola, Shwasa, Hridaspandan, Aruchi, Akshi koota shotha, Pindikoudveshthan, Bhrama, Rukshata, Gourava and Shrama.
2.Participants having Hb% between 8gm% -12 gm%
3.Males and females between age group 15-49 years |
|
| ExclusionCriteria |
| Details |
1.Participants having history of Haemoglobin less than 7
2.Participants suffering from haematological disorders such as sickle-cell anaemia andthalassemia are excluded.
3.Participants having history of systemic disorders such as uncontrolled hypertension, uncontrolled diabetes mellitus, AIDS, and cancer.
4.Pregnant females and lactating mothers.
5.Gynaecological diseases like Menorrhagia and Obstetric disorders leading to bloodloss
6.Participants coming in Grishma and Sharad Ritu will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased Hb percent and reduction of symptoms of pandu |
Every 7th day for 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of this study is to observe and evaluate any adverse reactions or side effects that may occur during the administration of Dahanadi Churna along with Dhatri Loha in the management of Pandu Vyadhi. |
21 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/06/2025 |
| 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
|
This study, titled “Randomized Controlled Clinical Trial of Add-On Effect of Dahanadi Churna with Dhatri Loha in Management of Pandu Roga,” investigates the enhanced therapeutic efficacy of combining Dahanadi Churna with Dhatri Loha in the treatment of Pandu Roga, a condition akin to iron deficiency anemia, the research involved 80 participants aged 15–49, divided equally into two groups—one receiving Dhatri Loha alone and the other receiving it in combination with Dahanadi Churna. The trial aimed to determine whether the addition of Dahanadi Churna, known for its digestive and metabolic stimulant properties, could improve iron absorption and thus lead to better clinical outcomes. Assessment was done over 21 days using both subjective symptoms (such as pallor, fatigue, and breathlessness) and objective hematological parameters (like hemoglobin levels and red blood cell indices). The anticipated conclusion is that the combination therapy offers superior results in managing Pandu Roga compared to monotherapy with Dhatri Loha. |