| CTRI Number |
CTRI/2025/03/081710 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study To Evaluate the Efficacy of Ayurvedic Management in Stage 4 Cancer(Arbuda) |
|
Scientific Title of Study
|
An Open Label Single Arm Clinical Study to Evaluate the Efficacy of Ayurvedic Comprehensive Management of Stage 4 Cancer Vis-a-Vis Arbuda |
| 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 Spoorthi S N |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No1 |
| Address |
JSS Ayurveda Medical College and Hospital Kayachikitsa Department OPD No 1
41 E Lalithadripura Road Alanahalli
Mysore
KARNATAKA
570028
India |
| Phone |
9606208682 |
| Fax |
|
| Email |
snspoorthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Beena M D |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No 1 |
| Address |
JSS Ayurveda Medical College and Hospital Kayachikitsa Department OPD No 1
41 E Lalithadripura Road Alanahalli
Mysore
KARNATAKA
570028
India |
| Phone |
9538367282 |
| Fax |
|
| Email |
drpbsreddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Beena M D |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No 1 |
| Address |
JSS Ayurveda Medical College and Hospital Kayachikitsa Department OPD No 1
41 E Lalithadripura Road Alanahalli
Mysore
KARNATAKA
570028
India |
| Phone |
9538367282 |
| Fax |
|
| Email |
drpbsreddy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Materials required for the treatment Gandira Rasayana and Haritakyadi Yoga will be prepared from GMP Certified pharmacy and Nithyananda Rasa and Gugguluthiktaka ghrita will be procured from GMP certified pharmacy |
|
|
Primary Sponsor
|
| Name |
Dr Spoorthi S N |
| Address |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No 1
41 E Lalithadripura Road Alanahalli |
| Type of Sponsor |
Other [SELF] |
|
|
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 Spoorthi S N |
JSS Ayurveda Medical College and Hospital Kayachikitsa OPD No 1 |
JSS Ayurveda Medical College and Hospital Kayachikitsa Department OPD No-1
41 E Lalithadripura Road Alanahalli Mysuru 570028
Mysore
KARNATAKA |
9606208682
snspoorthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee- Human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D499||Neoplasm of unspecified behavior of unspecified site. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guggulu tiktaka ghrita, Reference: Astanga Hridaya Vatavyadhi Chikitsa, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Hot water or Warm milk), Additional Information: -(2) Medicine Name: Nithyananda Rasa, Reference: Bhaishajya Ratnvavali Shleepada Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: -(3) Medicine Name: Gandira Rasayana, Reference: Sahasrayoga Lehya Prakarana, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -(4) Medicine Name: Haritakyadi Yoga, Reference: Charaka Samhita Rasayana Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Jaggery Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between the age group of 18-80 years irrespective of gender, religion and socio-economic status, type or site of stage 4 cancer |
|
| ExclusionCriteria |
| Details |
1.Subjects who are not able to take oral medicines
2.Patients with systemic disorders which interfere with the treatment (CKD, Cardiac diseases) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Ayurvedic comprehensive Management of Stage 4 Cancer |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Ayurvedic comprehensive Management of Stage 4 Cancer |
Total number of assessment-7
Pre test: On 0th day
Number of mid test -5 - on every 15th day
Post test - 90th day
Total study duration: 90 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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
|
•Neoplasm
or tumour is “ A mass of tissue formed as a result of abnormal, excessive,
uncoordinated, autonomous and purposeless proliferation of cells, even after
removal of growth stimulus which caused it”.
•Cancer
is a second leading cause of death globally. In India one in nine people are
likely to develop cancer in his/her lifetime. Recently India is been named the
Cancer capital of the world
•Depending
upon the stage of cancer, treatment modalities used are surgery, chemotherapy
and radiotherapy, hormonal treatment and Immunotherapy.
•Accessibility,
affordability, compromised quality of life and variable success rates are the
problem areas of conventional cancer care.
•In
classics, Cancer can be corelated with Arbuda
and is defined as a swelling occurring in any part of the body. Due to
vitiation of Tridosha,
afflicting Mamsa
Dhatu,
which is circular, fixed, slightly painful, big or widespread, deep seated,
slowly growing and non suppurative.
•Nityananda
rasa, Gandeera rasayana, Panchatikta guggulu ghrita mentioned
in Ayurvedic classics have direct indication in Arbuda, Gulma, Granti, Gandamala, Aruchi, Shwasa, Kasa.
Haritakyadi yoga which
helps in Deepana,
pachana, anulomana, purana mala shodhana;
These medicines can be administered in combination in the management of cancer.
•In
this study an effort is put forth to evaluate the combined effect of Nityananda rasa, Gandeera rasayana, Guggulu thiktaka ghrita and
Haritakyadi yoga in
the management of stage 4 cancer. |