| CTRI Number |
CTRI/2024/05/066586 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Palliative care] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Unani Palliative Care in cancer |
|
Scientific Title of Study
|
Impact of Unani Palliative Care through modulation in
Asbab- e- sita zaroriya (the six essential factors) among
the patients of Cancer undergoing treatment
(chemotherapy and/or radiotherapy) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anam Athar |
| Designation |
PG Scholar |
| Affiliation |
Ajmal khan tibbiya College AMU |
| Address |
Department of Tahaffuzi wa Samaji Tib Ajmal khan Tibiya College and Hospital Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
6395243503 |
| Fax |
|
| Email |
anam.athar03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abdul Aziz Khan |
| Designation |
Assistant professor |
| Affiliation |
Ajmal khan tibbiya College AMU |
| Address |
Department of Tahaffuzi wa Samaji Tib Ajmal khan Tibiya College and Hospital Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9760893505 |
| Fax |
|
| Email |
abdulaziznium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abdul Aziz Khan |
| Designation |
Assistant professor |
| Affiliation |
Ajmal khan tibbiya College AMU |
| Address |
Department of Tahaffuzi wa Samaji Tib Ajmal khan Tibiya College and Hospital Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9760893505 |
| Fax |
|
| Email |
abdulaziznium@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dawakhana Tibbiya College
near university fort, Aligarh, UP |
|
|
Primary Sponsor
|
| Name |
Dawakhana Tibbiya College |
| Address |
Qila Road, Qila, Aligarh Uttar Pradesh PIN 202001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Md Shadab Alam |
JNMCH, AMU, Aligarh |
Room no. 5 ,OPD of Radiation Oncology , JNMCH,Aligarh Muslim University
Aligarh
UTTAR PRADESH |
9634464879
roshanshadab@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Faculty of Unani Medicine Ajmal Khan Tibbiya College Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hab e papita 2 tab each of 500mg BD
Aujaiya 2 tab each of 500mg BD
Rogan e Banafsha Qs for LA HS |
Hab e papita for anorexia
Aujaiya for musculoskeletal pains
Rogan e Banafsha for Insomnia |
| Comparator Agent |
tab pantoprazole 1 tab 40mg bbf
tab tramadol 100mg in divided dose
tab zolpidem 1tab 10 mg HS
|
tab pantoprazole for anorexia
tab tramadol for pain
tab zolpidem for insomnia
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
clinically and histopathologically diagnosed cancer patients
Both Genders
Patients who have agreed to sign informed consent and follow up the protocol.
Patients attending the JNMC hospital. |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactations.
Cases other than cancer.
Patients who are not ready to sign informed consent and follow up the protocol. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| symptoms relived |
15 days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life improved |
6 months |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
11/05/2024 |
| 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="0"
Months="6"
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
|
Cancer is the second leading cause of death behind heart disease1. The total estimated burden of cancer for India in 2016 was 1277 DALYs per 100,000. After adjusting the MI ratio, the national cancer burden was 1908 DALYs AMI per 100,000 The top five leading causes of cancer DALYs in 2016 for males were lung (183.3 per 100,000), mouth (89.6 per 100,000), oesophagus (89.4 per 100,000), stomach (76.7 per 100,000) and liver cancers (74.9 per 100,000) excluding the other and unspecified sites. Prostate cancer contributed to 6.5 YLDs per 100,000 third to lung and mouth cancers. The most common causes of cancer DALYs among females were breast (232.7 per 100,000), cervix uteri (98.6 per 100,000), ovary (78.9 per 100,000), lung (74.1 per 100,000) and gall bladder (58.3 per 100,000) cancers2 Palliative care is an approach that improves the QoL of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial, and spiritual. In Unani system of medicine, the effect of surroundings and environmental conditions on the human health is described in detail. The main concern of this system is to restore the equilibrium of the core body temperature known as vital heat and maintain the health status of human being with the help of Tabiat (Physis) Keeping in view the prevalence of cancer and impact of palliative care in the improvement of QoL, the present study is designed to evaluate the efficacy of Palliative care through unani methods by modulation in Asbabe Sitta Zarooriya among the patients suffering from cancer. Objectives: 1. To assess the efficacy of palliative care through unani methods among the patients of cancer undergoing treatment (radiotherapy and/or chemotherapy) 2. Impact of palliative care through unani methods on the QoL among the patients of cancer undergoing treatment (radiotherapy and/or chemotherapy)
|