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CTRI Number  CTRI/2018/04/012964 [Registered on: 03/04/2018] Trial Registered Retrospectively
Last Modified On: 15/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dhoomapana therapy for cancers. 
Scientific Title of Study   Randomized open labelled clinical study to evaluate the efficacy, tolerability and safety of Dhoomapana therapy in patients of Head and Neck 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 and Head 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
411 030
India 
Phone  02024537149  
Fax    
Email  dr.bendale@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Poonam Birari  
Designation  Physician  
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  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
411 030
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  Rasayu Cancer Clinic Pune 
Address  B-1, Amrutkumbh, Laxmipark Soc., Navi peth, Opp. Sargam Hotel, Pune 411 030. Maharashtra, India. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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   Clinical Department 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 
IEC Rasayu Cancer Clinic pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Head and Neck Cancer ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ayurvedic Rasayana Therapy   Herbomineral ayurvedic rasayana formulations used in cancer therapautics. 
Intervention  Dhoompana as an add on with ayurvedic rasayana therapy   Inhalation of medicated fumes obtained by burning of somal (Arsenic Trioxide) along with other herbs and herbomineral formulations. DOSE - 8 to 10 Puffs TID. Route of administration -Nasal Inhalation 03 month duration of therapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Male and Female cancer patients suffering from head and neck cancers.
2.Cancer patients refractory to conventional line of treatment.
3. Cancer patients willing to take ayurvedic treatment for management of cancer. 
 
ExclusionCriteria 
Details  1. Patients taking conventional anticancer therapies.
 
 
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 
Health related quality of life as assessed by FACT-G   Day0,Day15, Day30,Day60,Day90. 
 
Secondary Outcome  
Outcome  TimePoints 
Tumor response as assessed radiologically.  Baseline (Day0), Day90 
Adverse events monitoring.  Baseline (Day0), Day30, Day60, Day90. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   27/03/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Head and Neck cancers pose a great challenge for physicians as well as patients. Dhoomapana is a therapy mentioned in Ayurveda for various oral as well as Head and Neck related disorders .In this therapy fume of various herbometallic formulations are delivered directly over the lesions.

This is a prospective open labelled study to evaluate safety, efficacy and tolerability of patients undergoing Dhoompana therapy by using a self designed questionnaire called Dhoomapana Efficacy and safety assessment questionnaire.(DESA). We will plan to design two groups. In group A Subjects will receive Rasayana therapy (AMRUT) for their disease and in Group B – Subjects will receive Rasayana therapy (AMRUT) along with Dhoomapana according to eligibility criteria. The benefits of this research will be to understand how non pharmacological interventions such as Dhoompana therapy can help manage Head and Neck cancer related symptoms and tumor regression.   
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