| CTRI Number |
CTRI/2025/01/079816 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| 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)= "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)
|
10/02/2025 |
| 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="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
|
In ayurveda, Vikara is caused by dhatuvaishamya. According to Acharya Charaka, Rasayana means the way for attaining excellent rasa and other dhatus. In other words, it can be stated that Rasayana is a way to achieve homeostasis or samyata of dhatus. Rasayana can be understood as nutritional dynamics for rejuvenation of body and psyche. As per Dalhana teeka, Rasayana is divided in three types on the basis of needs. The term “Naimittika” is derived from the word Nimitta which means cause or etiology, which is the reason for the Vyadhi (diseases) manifestation. The term Rasayana means rejuvenation or promoter of vitality. Thus, Naimittika type of Rasayana can be defined as Rasayana specific to a disease which will improve the vitality of individual towards the specific disease. Management of Pandu Roga could be planned with two different approaches. 1. Supplementation of the drugs having similar properties of Rakta (Loha, Kasisa or Mandura preparations.) 2. By the correction of System through Rasayana chikitsa. Considering the conceptual topic of this research work, here second approach is selected for the management of Pandu Roga to understand the applied utility of Rasayana Chikitsa. |