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CTRI Number  CTRI/2024/09/073296 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Unani polyherbal formulation along with tuberculosis treatment(DOTS therapy) in newly diagnosed tuberculosis patients 
Scientific Title of Study   Efficacy of Unani polyherbal formulation as an adjunct therapy in category-I tuberculosis patients on DOTS therapy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MAHERA SAMRIN 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore, Karnataka- 560091, India

Bangalore
KARNATAKA
560091
India 
Phone  8095267429  
Fax    
Email  maherasamrin786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ZARNIGAR 
Designation  Professor 
Affiliation  National Institute of Unani Medicine 
Address  Department of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore, Karnataka- 560091, India

Bangalore
KARNATAKA
560091
India 
Phone  7483244027  
Fax    
Email  kzarnigar15@gmail.com  
 
Details of Contact Person
Public Query
 
Name  MAHERA SAMRIN 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Tahaffuzi wa Samaji Tib, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore, Karnataka- 560091, India

Bangalore
KARNATAKA
560091
India 
Phone  8095267429  
Fax    
Email  maherasamrin786@gmail.com  
 
Source of Monetary or Material Support  
Department of Tahaffuzi wa Samaji Tib, OPD and IPD of National Institute of Unani Medicine Hospital, Kottigepalya, Magadi Main Road, Bangalore, Karnataka- 560091, India. Material Support- PHCs of Bangalore providing DOTS treatment. 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore, Karnataka- 560091, 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 MAHERA SAMRIN  National Institute of Unani Medicine Hospital  Department of Tahaffuzi wa Samaji Tib, OPD and IPD Block of National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore, Karnataka- 560091, India
Bangalore
KARNATAKA 
8095267429

maherasamrin786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethics Committee (IEC) for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A150||Tuberculosis of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DOTS treatment  Patients receiving DOTS treatment is considered as a standard control in another group. Control group will be treated with only DOTS for 2 months. 
Intervention  DOTS treatment with Unani polyherbal formulation  Unani polyherbal formulation (Joshanda) consists of following drugs : 1. Banafsha (Viola odorata)- 1gm, 2. Aslasoos (Glycyrrhiza glabra)- 1gm, 3. Unnab (Ziziphus jujuba)- 1.28gm, 4. Sapistan (Cordia latifolia)- 1gm, 5. Maveez munnaqa (Vitis vinifera)- 1.42gm, 6. Amaltas / Khiyar Shambar (Cassia fistula)- 3.42gm, 7. Turanjabeen (Alhagi pseudalhagi)- 3.42gm. The ingredients of the decoction will be identified in crude form. The drugs will be cleaned to remove any unwanted material and impurities and then powdered. 10gm of the coarsely powdered formulation has to be soaked in 2 cups of water for 10-12hrs, then boil until the original volume is reduced to its half. Strain out the herbs using a filter and the filtrate obtained will be consumed as a whole 2 times a day. Test group will be treated with Unani polyherbal formulation decoction twice a day along with DOTS for 2 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who have evidence of active tuberculosis (defined as having symptoms of fever or cough and a sputum smear that showed Acid fast bacilli or a chest X-ray that shows changes compatible with a diagnosis of tuberculosis).
2. Age between 18-60 years.
3. Patients of either sex.
 
 
ExclusionCriteria 
Details  1. Patients who are hypersensitive to ATTs being administered.
2. Patients already started on ATT for more than 1 week.
3. Patients co-infected with HIV, hepatitis, malignancy, other co-morbid
diseases, COPD and uncontrolled DM and hypertension.
4. Pregnant and lactating females.
5. Seriously ill patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of :
1. Symptoms
2. Sputum smear, Complete haemogram, CRP, LFT, RFT 
1. 0th, 15th, 30th, 45th and 60th days
2. 0th, 30th and 60th days 
 
Secondary Outcome  
Outcome  TimePoints 
Chest X-ray  Before and After the treatment 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2 
Date of First Enrollment (India)   03/09/2024 
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="1"
Months="0"
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  

Tuberculosis (TB) is a specific infectious disease caused by Mycobacterium tuberculosis. The disease primarily affects the lungs and causes Pulmonary Tuberculosis. It is one of the world’s major communicable infectious diseases, and it still imposes a great health burden in developing countries. It is one of the leading causes of mortality worldwide. According to World Health Organization (WHO), 10.4 million TB patients were reported in 2016, with annual death of 1.7 million. Of global total, India had 26% of reported TB death in the same year. Today it ranks as the second leading cause of death from an infectious disease worldwide, after the human immunodeficiency virus. An estimated one third of the world population has been infected. India remains the highest TB burden country giving an estimated incidence of 2.2 million cases out of a global incidence of 9.6 million cases.

 The predominant symptoms of active TB are fever, night sweat, weight loss and chronic cough with blood containing sputum. Most of the people do not show signs of TB disease (termed latent infection). However, most TB infections which are latent may progress into active disease if left untreated.

 Treatment of TB using Directly Observed Treatment Short – course (DOTS) therapy comprises multiple antibiotics is quite lengthy and causes serious side-effects in different organs.  The length of the TB treatment leads to withdrawal from the patients, which paves the way for the emergence of drug resistance in bacterial population. Due to the side effects of the drugs, poor medication compliance and the problem of development of drug -resistant TB, global investment in TB research is needed. Among the first-line anti-Tb drugs, side effects of hepatotoxicity have been reported to be associated with isoniazid, rifampicin and pyrazinamide; cutaneous reactions with isoniazid, pyrazinamide and ethambutol. Long-term respiratory symptoms and impairment of pulmonary function affect patients’ quality of life. 

The key objective is to discover and develop new drugs that can improve treatment strategy, enhance safety and address both infection and side effects. These concerns related to therapy need serious and immediate interventions. In absence of effective therapeutic drugs for TB, hope is built on plant based natural products due to their chemical diversity and important role as phyto-drugs. 

In ancient Unani literature, the physicians termed Tuberculosis as Diq and Sil and described TB under both headings separately. Sil being emaciation and Diq means low- grade fever which is one of the cardinal symptoms of the disease.

Unani physician, Abu Bakr Mohammed Bin Zakriya Razi (Rhazes) has mentioned a formulation in his book Kitab al Hawi for intense fever and roughness of lungs in Tuberculosis. The following drugs: Banafsha, Aslasoos, Maweez munnaqa, Sapistan, Unnab, Khiyar shambar and turanjabeen are given in the form of Joshanda(decoction).  Recent studies showed that these drugs have properties like antioxidant, immunomodulator, anti-tubercular, hepatoprotective and anti-inflammatory. These drugs are easily available and cost effective. Hence,this study is intended to evaluate the effect of Unani polyherbal formulation as an adjunct therapy in newly diagnosed Pulmonary Tuberculosis patients.

 
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