| 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
|
|
|
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
|
|
|
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. |