| CTRI Number |
CTRI/2026/01/100953 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| 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
|
This research studies how well Ayurvedic medicines(Ayorajvyoshaadya Churna, Phaltrikaadi Kwatha)and Panchkarma therapy (virechan karma) work in improving anaemia. |
|
Scientific Title of Study
|
An Open Label Randomised Controlled Clinical Study to evaluate the efficacy of Ayorajvyoshaadya Churna,Phaltrikaadi Kwatha and Virechana Karma in the Management of Pandu Roga w.s.r. to Iron Deficiency Anaemia |
| 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 Vijay Chaudhary |
| Designation |
Principal-Cum-Dean |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayuvedic College and Hospital Paprola |
| Address |
Room no.317 Hospital Building Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital Paprola , Distt Kangra(H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr Vijay Chaudhary |
| Designation |
Principal-Cum-Dean |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayuvedic College and Hospital Paprola |
| Address |
Room no.317 Hospital Building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ishani Kaushal |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayuvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805708796 |
| Fax |
|
| Email |
ishanikaushal462@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt Kangra 176115, Herbal garden and Herbarium, Research Institute in ISM, Joginder Nagar, Distt. Mandi 175015 |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College and Hospital Paprola Distt Kangra |
| Address |
Room no 317 Hospital Building Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra |
| 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 |
| ProfDr Vijay Chaudhary |
RGGPG College and Hospital Paprola Kangra |
Room no.317 Hospital Building Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital Paprola , Distt Kangra(H.P.)
Kangra
HIMACHAL PRADESH |
09418130228
drvijaychaudhary@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 |
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 | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: charak samhita chikitsa sthan 16/40, Procedure details: Purvakarma
Deepan Pachan- It will be performed by the administration of Trikatu Churna 3 g twice daily before food with lukewarm water till the symptoms of appropriate Agni Deepana were attained by Trikatu Churna.
Snehpana- Dadima Ghrita
DOSE- Snehpana Dadima Ghrita will be initiated from the dose of 40ml and will be continued for 3-7 days in increasing pattern depending upon Koshtha and Agni of the individual till the appearance of Samyak Snehan Lakshana.
Sarvang Abhyanga and Swedana
After appearance of Samyak Snehan Lakshana, the next 3 days and on the day of Pradhanakarma i.e. the fourth day Sarvanga Abhyanga with Murchita Til Taila will be performed followed by Sarvanga Swedana.
On the previous day of Pradhankarma, individual will be asked to take Laghu,
Snigdha, Drava, Ushna Ahara.
Diet should be such that it should not increase kapha as it may cause Vaman. Sushrut Samhita advised light diet. (Su.Ch.31/20)
Pradhankarma
Virechan Dravya – Trivrit Churna.
Form used - Powder form
Dose – After the Koshtha assessment of the individual Virechan Karma will be carried out as per Ayurvedic text. Minimum 6gm and maximum 12gm.
Anupana – Ushana Jala
Paschatkarma
Samsarjana Krama: Samsarjana Krama will be advised for 4, 8, 12 Annakala upto 3 (4 Annakala), 5 (8 Annakala), 7 (12 Annakala) days depending upon Hina, Madhya, Pravara Shudhi respectively.
Pariharya (Behavioural & Dietary restrictions)
)
(1) Medicine Name: Ayorajvyoshaadya Churan, Reference: Susrut Uttartantra 40/19, Route: Oral, Dosage Form: Capsules, Dose: 375(mg), Frequency: bd, Duration: 12 Weeks | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous Sulphate | Ferrous Sulphate 200mg once a day 2 hour after meal |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals of either gender between the age of 18-60 years.
2 Patients who present with sign and symptoms of Pandu Roga w.s.r. to Iron Deficiency Anaemia as described in classical texts.
3 Patients having low haemoglobin concentration i.e. Hb gm% for male 8-12gm% and female 8-11gm%.
4 MCV - below 70fl
5 Patients willing and able to participate for 12weeks duration.
|
|
| ExclusionCriteria |
| Details |
1 Patients suffering from chronic respiratory, cardiac disorder, CKD, Diabetes Mellitus, Rheumatoid Arthritis
2 Patients suffering from other major illness like carcinoma, tuberculosis or any other condition considered to be unfit for enrolment on the trial.
3 Hb lessthan 8 gm per dl.
4 Iron deficiency due to loss of blood from intestine& other sites.
5 Iron deficiency anaemia necessitates parental iron therapy.
6 Intake of Iron supplement for 3months before the initiation of study.
7 Participant with hepatic dysfunction (defined as AST &ALT, 2 times more of upper limit).
8 Participant with renal dysfunction i.e., S. creatinine level should not be more than 1.2mg per dl.
9 Patients who are pregnant and lactating mothers
10 History of hypersensitivity to any of the trial drug or its ingredients.
11 Individuals who have completed participation in any other clinical trial during the past three months.
12 History of active substance abuse
13 Any other condition which the principal investigator thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To clinically evaluate the efficacy of Ayorajvyoshaadya Churna, Phaltrikaadi Kwatha and Virechana Karma in the management of Pandu Roga w.s.r. to Iron Deficiency Anaemia. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the efficacy of Ayorajvyoshaadya Churna, Phaltrikaadi Kwatha and Virechana Karma with Tablet Ferrous sulphate in the management of Pandu Roga w.s.r. to Iron Deficiency Anaemia.
• To assess the clinical safety and untoward effects of Ayorajvyoshaadya Churna and Phaltrikaadi Kwatha and Virechana Karma in patients of Pandu Roga w.s.r. to Iron Deficiency Anaemia.
|
12 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
06/05/2026 |
| 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="3"
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
|
i would like to publish my research trial after completion as soon as possible.A total of 30 subjects will be studied in 2 groups, 15 study subjects with Virechana Karma, Ayorajvyoshadya Churna 375mg twice a day after meal, Phalatrikadi Kwatha 50ml twice a day after meal and 15 study subjects will be ,managed with Ferrous Sulphate 200 mg once a day.The outcome will be analysed with both Subjective and Objective criteria with appropriate statiscal tool. |