| CTRI Number |
CTRI/2026/01/100701 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the efficacy of Triphala Mandoora in the Management of Pandu Roga (Iron Deficiency Anemia) |
|
Scientific Title of Study
|
A Randomized Controlled Open Label Clinical Study to evaluate the efficacy of Triphala Mandoora in the Management of Pandu Roga w.s.r to 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 Manik Soni |
| Designation |
Senior Lecturer ,PG Department of Kayachikitsa |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Kayachikitsa ,Room number 317,Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
82191210414 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manik Soni |
| Designation |
Senior Lecturer ,PG Department of Kayachikitsa |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
PG Department of Kayachikitsa ,Room number 317,Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
HIMACHAL PRADESH
176115
India |
| Phone |
82191210414 |
| Fax |
|
| Email |
drmsony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan Dhiman |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,Paprola |
| Address |
PG Department of Kayachikitsa ,Room number 317,Rajiv Gandhi Govt Post
Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219360386 |
| Fax |
|
| Email |
kanchandhiman773@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola,
,176115 ,Kangra, H.P.,INDIA |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,
Paprola, Distt. Kangra, H.P. 176115, India |
| 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 |
| Dr Manik Soni |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
Room No.317, Rajiv
Gandhi Govt Post
Graduate Ayurvedic
College and Hospital,
Paprola, Distt. Kangra,
H.P. 176115, India
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
8219121014
drmsony@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. ,176115, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Mandoora, Reference: Ayurveda Sar Sangraha ( Loha Mandoora Prakarana), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous Sulphate | 200mg once a day two hour after meal |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having sign and symptoms of Pandu roga
2.Hb
Male less than 8-12gm
Female less than 7-11 gm
3.Patients willing and able to participate for 8 weeks duration .
4.Indivisuals of either gender between the age 18 -60 years
|
|
| ExclusionCriteria |
| Details |
1.Patients not following in inclusion criteria .
2.Patients suffering from chronic respiratory and cardiac disorder ,CKD or other major illness like carcinoma .
3. Patients who has completed participation in any other clinical trial during the past 3 Month |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptom of pandu (Iron Deficiency anemia) |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the safety of TRiphala Mandoora in the management of Pandu Roga (Iron Deficiency anemia ) |
30 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients
will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital,Paprola. 2 groups of 30
patients will be registered and assessed to evaluate the efficacy of Triphala Mandoora in the management of Pandu Roga w.s.r to Iron Deficiency Anemia. |