| CTRI Number |
CTRI/2016/02/006658 [Registered on: 18/02/2016] Trial Registered Prospectively |
| Last Modified On: |
17/02/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Uses of Bhanga(Cannabis sativa Linn)in cancer patients |
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Scientific Title of Study
|
A study on impact of shodhana on Phyto-pharmacological properties and biological actions of Bhanga (Cannabis sativa Linn)leaf
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swagata Dilip Tavhare |
| Designation |
Ph D Scholar |
| Affiliation |
IPGT and RA GAU Jamnagar |
| Address |
Department of Dravyaguna Vigyan IPGT and RA GAU Jamnagar GUJARAT361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9723163298 |
| Fax |
|
| Email |
drswagata32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rabinarayan Acharya |
| Designation |
Professor |
| Affiliation |
IPGT and RA GAU Jamnagar |
| Address |
Department of Dravyaguna Vigyan IPGT and RA GAU Jamnagar GUJARAT
361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Rabinarayan Acharya |
| Designation |
Professor |
| Affiliation |
IPGT and RA GAU Jamnagar |
| Address |
Department of Dravyaguna Vigyan IPGT and RA GAU Jamnagar GUJARAT
361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
drrnacharya@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
IPGT and RA GAU Jamnagar |
| Address |
IPGT and RA GAU Jamnagar 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurved cancer research institute RRA Podar Worli Mumbai CCRAS Ayush MH and FW govt of India |
Podar medical campus Dr Annie Besant road Worli Mumbai 400018 |
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swagata Tavhare |
PG hospital IPGT and RA Jamnagar and ACRI RRA Podar Worli Mumbai |
1 IPGT and RA Gujarat
Ayurved University
Jamnagar -361008 Gujarat
2 Podar medical campus Dr Annie Besant road Worli Mumbai 400018
Jamnagar
GUJARAT |
9723163298
drswagata32@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
The patients receiving the any type of available standard or ayurvedic management for cancer with pain as a main symptom with poor quality of life , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Analgesics |
Analgesics at a dose upto 500mg TDS |
| Intervention |
Processed powder of Bhanga in capsule form |
Experimental studies to decide the dose is underway. The decided dose will be administered along with milk and sugar as adjuvant. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Institutionally diagnosed patients of any type of cancer with pain and ECOG score upto 3.
2) Patients willing to participate in trials.
3) Patients of either sex aged between 18 – 70 years
4) Patients undergoing any type of standard palliative treatment for cancer except for pain management.
|
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| ExclusionCriteria |
| Details |
1) Systemic diseases like uncontrolled hypertension, uncontrolled diabetes, heart diseases, Lung diseases, hepatic and renal dysfunctions.
2) Pregnancy and breast feeding women.
3) Cancer patients with ECOG more than 3.
4) Patients with inability to comprehend and complete the proposed course study as per instructions.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Primary expected outcome will be reduction in pain and improvement in quality of life and overall associated symptoms in cancer patients |
1 month drug intervention and 1 week follow up |
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Secondary Outcome
|
| Outcome |
TimePoints |
| Development of shodhit i e purified Bhanga churna in the management of improving quality of life in cancer patients specially as a analgesic agent |
1 year |
|
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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" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2016 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Clinical Observations will be published in peer reviewed journals |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
The drug Bhanga(Cannabis sativa L) has been well reported in the management of post-chemotherapy, post radiation therapy induced side effects and also on cancer symptoms like anorexia, indigestion, depression ,anxiety etc.Being poisonous it has been limited from clinical practice due to its ill effects thus classics advise its shodhana. Classics has mentioned various methods of Bhanga shodhana (purification) as follows:
1)The leaves of Cannabis are tied in a cloth and washed in water which gives a greenish appearance to the water. This process has to continue until the greenish colour stops oozing from the leaves. Afterwards leaves are shade dried. 2) The dry leaves washed in water and subjected to drying under sun and later on roasted with cow ghee. 3) Fomentation(Swedan) of leaves in cow milk for approx. 3hours then washed with water and roasted in ghee. 4) Fomentation in the decoction of Acacia Arabica Willd (Mimosaceae) bark (Babbul twak) for Ghatikardha(12min) with moderate heat and then subjected to drying under sun. Further triturated with cow milk and again dried.
· A pilot study will be done to assess the efficacy of shodhana of Bhanga in improving quality of life in cancer patient’s w.s.r to pain management.Total 40 patients will be studied in one group 20 patients will received morphine as a standards analgesic drug upto 500mg TDS dose and other group 20 patients will receive shodhit (processed)Bhanga churna capsule form in appropriate dose (drawn from animal study) for 30 days followed by follow up of one week to observe withdrawal changes if any.Washout period for morphine will be kept as seven days but in severe pain cases it will be reduced upto 3 days.
Chief complaints will be assessed by
1) Wong baker faces scale for pain
2) Neuropathy pain scale
3) Criteria of Assessment for anxiety and depression (Hospital and Anxiety Depression Scale(HADS) Generic)
Associated complaint swill be assessed by(if applicable)
1)Criteria for assessment for Quality of life in cancer patients (FACT G Scale)
2)(Profile of Mood States (POMS) Cancer specific ) 3) NCI–CTC grade for assessment of Nausea and Vomiting
4) National Cancer Institute Common Toxicity Criteria ) for Diarrhoea assessment
5)Criteria for assessment of Constipation (CAS)
6) Criteria for assessment of weight loss
7) Criteria for assessment for dryness of skin.
8) Criteria for assessment of hair loss
Adverse reactions any will be noted too. The duration of treatment for each patient will be for 1 month and follow up one week.
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