| CTRI Number |
CTRI/2018/05/014067 [Registered on: 23/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate effect of ayurvedic dhoompana therapy in patient with lung cancer. |
|
Scientific Title of Study
|
Randomized Open labeled clinical study to evaluate efficacy,tolerability and safety of Dhoomapana therapy in patients of Lung Cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Bendale |
| Designation |
Chairman |
| Affiliation |
Rasayu Cancer Clinic,Pune. |
| Address |
B-1, Amrutkumbh, Laxmipark Soc.,
Navi peth, Opp. Sargam Hotel,
Pune 411 030. Maharashtra, India.
Pune
MAHARASHTRA
411 030
India |
| Phone |
02024537149 |
| Fax |
|
| Email |
dr.bendale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Birari |
| Designation |
Physician Clinical Department |
| Affiliation |
Rasayu Cancer Clinic,Pune. |
| Address |
B-1, Amrutkumbh, Laxmipark Soc.,
Navi peth, Opp. Sargam Hotel,
Pune 411 030. Maharashtra, India.
Pune
MAHARASHTRA
411030
India |
| Phone |
02024537149 |
| Fax |
|
| Email |
poonam.birari84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Birari |
| Designation |
Physician Clinical Department |
| Affiliation |
Rasayu Cancer Clinic,Pune. |
| Address |
B-1, Amrutkumbh, Laxmipark Soc.,
Navi peth, Opp. Sargam Hotel,
Pune 411 030. Maharashtra, India.
Pune
MAHARASHTRA
411030
India |
| Phone |
02024537149 |
| Fax |
|
| Email |
poonam.birari84@gmail.com |
|
|
Source of Monetary or Material Support
|
| B-1, Amrutkumbh, Laxmipark Soc.,
Navi peth, Opp. Sargam Hotel,
Pune 411 030. Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Rasayani Cancer Clinics Pune |
| Address |
B-1 Amrutkumbh Laxmipark Soc Navi peth Opp Sargam Hotel Pune 411 030 Maharashtra India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Yogesh Bendale |
Rasayu Cancer Clinics Pune |
B-1, Amrutkumbh, Laxmipark Soc.,
Navi peth, Opp. Sargam Hotel,
Pune 411 030. Maharashtra, India
Pune
MAHARASHTRA |
02024537149
dr.bendale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Rasayu cancer clinic |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Lung Cancer , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ayurveda Rasayana Therapy |
Orally administered Ayurveda Rasayana therapy for a period of three months administered orally (Bid) |
| Intervention |
Rasayana Therapy with Dhoomapana as an addon therapy |
Duration: Nasal inhalation of dhoompana 8 to 10 puffs TID for three months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with Lung cancer or Lung metastasis.
2. Taking Ayurvedic treatment consisting of Dhoomapana
3. Willing to undergo treatment with Dhoomapana
|
|
| ExclusionCriteria |
| Details |
Patients who was suffering from any concomitant illness or taking any concomitant medication which in the opinion of investigator would have confounded with outcome efficacy variables.
Patient who were receiving Opoid analgesics.
Patient who were receiving other CAM modalities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
For assessment of efficacy, tolerability and safety of dhoomapana it is planned to use a self designed questionnaire called Dhoomapana Efficacy and safety assessment questionarrie.(DESA)
|
Each patient will be followed for a study duration of six months.
Study variable will be tested at a intervals of one month.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| for assessing disease specific efficacy the disease specefic component of Functional assessment of cancer therapies (FACT) questionarrie will be used. |
Each patient will be followed for a study duration of six months.
Study variable will be tested at a intervals of one month.
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/03/2015 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dhoomapana is a therapy mentioned in Ayurveda for various oral, respiratory as well as head and neck related disorders . Dhoomapana is found to be effective treating various respiratory disorders and is widely used by Ayurved practitioners. We are evaluating the effect of Dhoompana patients in managing symptoms and improving quality of life in lung cancer patients.
|