INTRODUCTION
Our Central Research Institute of Unani Medicine Lucknow is a subordinate Office of the Central Council for Research In Unani Medicine New Delhi which is an autonomous organization of Department of AYUSH, Ministry of Health and Family Welfare , Govt. of India.
This Institute was established in the year 1982 as Regional Research Institute of Unani Medicine and upgraded to Central Research Institute of Unani Medicine in the year 2000 and housed in different rented buildings . Presently the Institute is functioning at C-39, P.O. Sector-C Jankipuram , Tehri Pulliya Kursi Road , Lucknow and construction of own building at Basha village kursi Road is in progress.
Recently our Council has allotted two projects viz Soo –al- Qiniya and Zoaf-e-Masana to conduct clinical trials on some Unani pharmacopial drugs .For these projects case sheets and protocols have been designed by the Council . The same is submitted for reference , kind consideration and able guidance in this regard.
Basically the Institute is engaged in conducting Clinical trials on chronic diseases with different Unani formulations . Clinical trials earlier under taken on different formulations are
1. Eczema 2.Helminthisis 3. Rheumatoid Arthritis 4. Osteo Arthritis 5. Gingivitis 6. Tooth Hypersensitivity 7. Obesity 8. Diabetes Mellitus 9. Bars 10. Cosmetic disorders
Infrastructure :
General Out Patient Department (GOPD) In patient Department 25 Bedded (IPD) Research Out Patient Department Geriatric Out Patient Department for Elderly persons Specialty Out Patient Department (Paid) Mother & Child Health Care Unit Dental Out Patient Department Day Care Clinic Extension Counter at S.T.T. College Lucknow Pulse Polio Program at Institute Mobile Medicare and Research Programme School Health Program. Pathological & Biochemical Laboratories Statistical Section. Pharmacy section. Library Research Programmes Under trial
Wajaul Mafasil (Rheumatoid Arthritis) Tahajjur-e-Mafasil (Osteo Arthritis) Ziyabetus Sukkari (Diabetes Mellitus) Zahab –o-Mayil Asnan (Tooth Hypersensitivity) Warm-e-Lissa (Gingivitis) Saman-e-Mufrat (Obesity) Osteoporosis(Takhlaqul ezam)
Discussion on Protocols and Case Sheets
Vote of Thanks by Dr. Wasim Ahmad Assistant Director(Unani)
Dr. Rafath Mehmooda
Deputy Director Incharge
Respected Chairperson , Dignitaries and colleagues I feel great pleasure to welcome all of you. It is an honors that the first meeting of ethical committee commenced today with your graceful presence.
I once again thankful to Hon’ble chairman and members of the Committee for fruitful discussion of the session. Central Research Institute of Unani Medicine Lucknow Minutes of Ethics Committee Meeting First Ethics committee meeting of CRIUM, Lucknow was held on 24 th Feb.,2012 at conference hall of this Institute to discuss and finalize case sheets and protocols of Zoaf-e-Masana and Soo-al-Qiniya.
Following members of the committee attended the meeting under the chairmanship of Prof.(Dr.)Hifazat Husain Siddiqui, Dean Faculty of Pharmacy and advisor to Vice-chancellor, Integral University, Lucknow.
1. Dr. R.C. Murthy Senior Principal Scientist and Head Analytical Chemistry Section Indian Institute of Toxicology Research Lucknow.
2. Dr. C.S. Saimbi Principal Career Post Graduate Institute of Dental Sciences and Hospital, Lucknow.
3. Hakeem S.M.A.Hassan Deputy Director (Unani) , CRIUM, Lucknow.
4. Dr. Jawed Ahmed MD (Med.), Specialist Physician, Vivekananda poly Clinic, Lucknow.
5. Maulana Ateeq Ahmad Bastawee, Secretary, Islamic Fiqh Academy Darul uloom Nadwatul ulama Lucknow.
6. Dr. Abdul Quddus Khan Formerly Sr. Lecturer State Takmil-ut-Tibb College, Lucknow.
7. Mr. I.H. Farooqui, Advocate, Assistant Solicitor General of India, Lucknow Bench of Allahabad High Court, Lucknow.
8. Mr. Owais Mohd. Khan, C/o Bright Land Foundation, Islah Complex, Ring Road, Lucknow. 9. Dr. Rafath Mehmooda Deputy Director Incharge CRIUM, Lucknow.
The meeting was started at 2 P.M. First of all The Deputy Director Incharge welcomed the Chairman of the Committee and introduced to all members of the Ethics Committee, thereafter she highlighted about all the Research projects undertaken at the Institute .
Dr. Hifazat Husain, Chairman of the committee expressed his experience with Unani System of medicine since inception of the Council and pleased to know the Institute’s research work carried out till so for.
Dr, Hussain also appreciated the new research projects under taken at CRIUM, Lucknow for Clinical validation of Unani pharmacopial formulations in diseases of Zoaf-e-Masana and Soo-al-Qiniya respectively and expressed his satisfaction over selection of pharmocopial drugs by the Council as its efficacy and safety is already established. Chairman and members gone through the protocols and case Sheets of said projects.
Dr. Jawed Ahmed emphasized for the following modifications under inclusion and exclusion criteria of the patients of Zoof-e-Masana. So that more patients will be available for the study.
Patients having the age of 55-65 years may be selected for the study.
Female patients with mild cystitis may also be selected for the study with 30ml urine collection in bladder.
Male patients with mild Benign prostrate hypertrophy(BPH) may be consider for the study.
Patients having minor spinal cord injury may be consider for the study.
Dr. Saimbi pointed out about the assessment criteria of the results and said that U.S.G. must be done before and after treatment, chairman and members of the committee agreed with his opinion. Deputy Director Incharge of this Institute told that USG may be done from out sourcing.
At this point Dr. Jawed Ahmed emphasized to install a U.S.G. machine at CRIUM , Lucknow ,for smooth functioning of research work and he also suggested to provide one month training to any one Unani Physician of the Institute from Medical college in order to get output of the USG machine and to avoid patient’s difficulties.
Dr. Saimbi suggested to include the following assessment criteria for statistical analysis .
No urgency of Urine - 0
Mild - 1 Moderate - 2
Severe - 3
Incontinence- 4
Dr. Murthy pointed out that the consent form should be in bilingual or tri lingual so that the Patients may understand the objectives of the study for which he/she is selected for clinical trial. Dr. Murthy also suggested to include chi-square method to carry out Statistical Analysis of data.
Dr. Saimbi put his opinion for future meeting to made available copies of Protocol and case sheet at least 15 days in advance to go through its details.
Further Dr. Saimbi emphasized to include the following grading system( as in microbiology) in Protocol of Soo-al –Qinia, for assessment of the results.
- Absent
+ Mild
++ Moderate
+++ Severe
Chairman and members expressed over all satisfaction on well designed case sheet and protocol of Zoaf-e-Masana and Soo-al- Qiniya as discussed in the said meeting , except some minor changes which were pointed out by the members of the Committee for rectification. The committee has suggested to start registering patients for the trial.
At the end of the meeting Dr. Wasim Ahmed , Assistant Director (Unani) thanked to the chairman and members of the committee for fruit full discussion and comments on the said protocols and case sheets.
Date: 01.03.2012
Prof.(Dr.)Hifazat Husain Siddiqui Chairman, Ethics Committee, CRIUM, Lucknow