| CTRI Number |
CTRI/2025/01/079816 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of an ayurvedic rejuvenating formulation (Pippali Rasayana) in the management of Anemia (Pandu roga) |
|
Scientific Title of Study
|
Review on Rasayana Chikitsa with special reference to Pippali Rasayana as Naimittika Rasayana in 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 |
Dr Margi Kamlesh Somaiya |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College Junagadh |
| Address |
Dept of Ayurved Samhita Evam Siddhant, Government Ayurved College Junagadh, Gujarat
Junagadh
GUJARAT
362001
India |
| Phone |
7779045835 |
| Fax |
|
| Email |
margi.somaiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Siddhesh Pandya |
| Designation |
Professor Department of Ayurved Samhita Evam Siddhant |
| Affiliation |
Government Ayurved College Junagadh |
| Address |
Dept of Ayurved Samhita Evam Siddhant, Government Ayurved College Junagadh, Gujarat
Junagadh
GUJARAT
362001
India |
| Phone |
9426260140 |
| Fax |
|
| Email |
drsidh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Siddhesh Pandya |
| Designation |
Professor Department of Ayurved Samhita Evam Siddhant |
| Affiliation |
Government Ayurved College Junagadh |
| Address |
Dept of Ayurved Samhita Evam Siddhant, Government Ayurved College Junagadh, Gujarat
Junagadh
GUJARAT
362001
India |
| Phone |
9426260140 |
| Fax |
|
| Email |
drsidh@gmail.com |
|
|
Source of Monetary or Material Support
|
| As Im student of government institute, Raw drug will be supplied by one of the two government pharmacies of Gujarat i.e. Government Ayurved Pharmacy Rajpipala - 393145 or Government Ayurved Pharmacy Vadodara - 390019 state: Gujarat, Country: India
And other expenses will be borne by myself |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College Junagadh |
| Address |
Pancheshwar road, Junagadh-362001 Gujarat |
| 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 |
| Prof Siddhesh Pandya |
Government Ayurveda Hospital Junagadh, Gujarat |
Department of Samhita Siddhant, Pancheshwar road, near Kadiyawad , Kadiawad, Junagadh- 362001, Gujarat
Junagadh
GUJARAT |
9426260140
drsidh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Government Ayurveda College Junagadh, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D539||Nutritional 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: Pippali Rasayana, Reference: Charaka Samhita chikitsa sthana, Rasayana chikitsa, Karprachitiya Rasayanapada, shloka no 33-35, Route: Oral, Dosage Form: Churna/ Powder, Dose: 750(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippali Rasayana, Reference: Charaka Samhita chikitsa sthana, Rasayana chikitsa, Karprachitiya Rasayanapada, shloka no 33-35, Route: Oral, Dosage Form: Churna/ Powder, Dose: 750(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippali Rasayana, Reference: Charaka Samhita chikitsa sthana, Rasayana chikitsa, Karprachitiya Rasayanapada, shloka no 33-35, Route: Oral, Dosage Form: Churna/ Powder, Dose: 750(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Age group: 18-60 years of either sex b) Patients having classical signs and symptoms of Pandu Roga i.e. Panduta (Netra, Jihva, Nakhagata Panduta), Daurbalya, Shrama, Hridspandana, Pindikodwestana, Bhrama, Kshudra shwasa & Aruchi c) Patients having Panduta (Any from three - Netra, Jihva, Nakhagata Panduta) as a compulsory symptom along with any three symptoms out of other 7 symptoms
|
|
| ExclusionCriteria |
| Details |
a) age below 18 years and above 60 years
b) Chronicity more than one year.
c) Pregnant and lactating women.
d) Chronic diseases like Diabetes Mellitus & Hypertension.
e) Patients having Pandu Roga due to bleeding disorders, genetics or other secondary causes.
f) Patients having major systemic disease or history of chronic diseases such as CKD (Chronic Kidney Disease), tuberculosis, cancer and autoimmune diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of the study it is expected that this study would be able to provide the efficacy of Pippali Rasayana in the management of Pandu roga. |
After 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out changes in the signs and symptoms of Pandu roga after 15 days of completion of trial medicine I e. Pippali Rasayana |
After 15 days of completion of trial medicine |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
14/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Introduction: A review of Rasayana Chikitsa, its modern aspects, Pandu Roga, its modern correlation, and Pippali Rasayana was carried out. The drug review also included Pippali Rasayana and the drugs used for Koshtha Shuddhi. Significance: The study was undertaken to evaluate the efficacy of Pippali Rasayana as a Naimittika Rasayana in the management of Pandu Roga. Aim & Objectives: To evaluate the clinical efficacy of Pippali Rasayana as Naimittika Rasayana in Pandu Roga and to study its pharmaceutical aspects and effect on the clinical manifestations of the disease. Materials and Methods: A total of 33 patients were enrolled, of whom 2 were lost to follow-up and 31 were available for analysis. After Koshtha Shuddhi and advice regarding Pathya-Apathya, Pippali Rasayana was administered at 750 mg three times daily for 30 days, followed by a 15-day follow-up. Assessment was done using predefined grading criteria for eight chief complaints and associated complaints. Appropriate parametric and non-parametric statistical tests were applied. Results and Discussion: Significant improvement was observed in the assessed clinical parameters following treatment with Pippali Rasayana (p < 0.001). Follow-up: Patients were assessed on the 45th day to evaluate the status of clinical parameters after completion of treatment and follow-up. Adverse Effects: No adverse drug reactions were reported during the study period. Conclusion: Pippali Rasayana showed significant improvement in the assessed clinical parameters and was found beneficial in the management of Pandu Roga. |