| CTRI Number |
CTRI/2024/04/065064 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effect of Unani drug in the Treatment of Chronic Cervicitis |
|
Scientific Title of Study
|
A clinical evaluation of polyherbal formulation in the management of Warm -e- unq-ur-rahem muzmin (Chronic Cervicitis)-An open label single arm study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Tanzeela khan |
| Designation |
PG student |
| Affiliation |
Ayurvedic and unani Tibbia college and hospital |
| Address |
Department of ilmul qabalat wa amraz e niswan OPD NO 14, Ayurvedic and Unani Tibbia college and hospital karol bagh New delhi
Central
DELHI
110005
India |
| Phone |
9084427391 |
| Fax |
- |
| Email |
tanzeela.khan4001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shahana Ayub |
| Designation |
Assistant professor |
| Affiliation |
Ayurvedic and Unani tibbia college and hospital |
| Address |
Department of ilmul qabalat wa amraz e niswan OPD NO 14, Ayurvedic and Unani Tibbia college and hospital karol bagh
Central
DELHI
110005
India |
| Phone |
8077530209 |
| Fax |
- |
| Email |
shahanaayub86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Tanzeela khan |
| Designation |
PG student |
| Affiliation |
Ayurvedic and Unani tibbia college and hospital |
| Address |
Department of ilmul qabalat wa amraz e niswan OPD NO 14, Ayurvedic and Unani Tibbia college and hospital karol bagh
Central
DELHI
110005
India |
| Phone |
9084427391 |
| Fax |
- |
| Email |
tanzeela.khan4001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia college and hospital |
| Address |
Ayurvedic and Unani Tibbia college and Hospital |
| Type of Sponsor |
Government medical college |
|
|
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 Tanzeela khan |
Ayurvedic and Unani Tibbia College and hospital ,Karol Bagh |
Department of Ilmul Qabalat wa Amraze Niswan,OPD no-14,Ayurvedic and Unani Tibbia college and hospital karol bagh
Central
DELHI |
9084427391
-
tanzeela.khan4001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia College karol bagh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extract of Unani polyherbal formulation Neem (Azadirachta indica) Mundi( Sphaeranthus indicus linn) Kasni (Chicorium intybus) Methi (Trigonella foenum) Revandchini (Rheum emodi) Mazoo (Quercus infectoria) Asgandh (Withania somnifera) filled in capsule form |
Two capsules of 500mg twice a day orally for two weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Married women in the age group of 18 to 45 years having vaginal discharge.
2. Patient giving history or complaint of the passage of mucopurulent cervical discharge with or without foul smell.
3. Patient with complaints of lower backache.
4. Patient with complaints of intermenstrual spotting and post-coital bleeding.
6. Patient having symptoms of dyspareunia and dysuria.
7. Patient having complaints of vulval Itching.
8. On P/S examination there may be findings of Nabothian follicles, congestion, and hyperplasia of cervix.
|
|
| ExclusionCriteria |
| Details |
1. The patient was unwilling to sign the consent form.
2. The patient has a history of AIDS, syphilis, gonorrhea or any other sexually transmitted disease.
3. History of cardiovascular, renal, liver disease.
4. History of diabetes mellitus .
5. Patients with systemic disease and malignancy.
6. Individuals of alcohol abuse or any other substance abuse.
7. Unmarried and pregnant women.
8. Women having a history of conisation, cryotherapy, and cauterization will also excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS Score (visual analogue scale),PS/PV Examination and PAP Smear will be assessed
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Abnormal cervical discharge,
Lower backache, Vulval Itching,
Foul smell in Vaginal Discharge will be assessed
|
12 weeks |
|
|
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" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="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
|
This study is an open label single arm trial to validate the efficacy, safety of of the extract form of Unani polyherbal formulation in the treatment of warm-e-unq-ur-rahem muzmin (chronic cervicitis) and reducing the symptoms of chronic cervicitis . Common complaints of patients include pelvic pain , vaginal discharge ,lower abdomen cramping ,intermenstrual bleeding, spotting with intercourse or dysuria. Cervix acts as a barrier to protect the uterus from entering infections (i.e bacteria ,viruses), if cervix remain unhealthy there is an increased risk of uterine infections. Chronic cervicitis has become more distressing problem problem, despite advancement of modern science. Chronic Cervicitis that is caused by Gonorrhea or Chlamydia can spread to uterine lining and fallopian tubes resulting in pelvic inflammatory disease (PID). PID is an infection of the female reproductive organs that can cause fertility issues if left untreated.( eg. ectopic pregnancy, adhesions in uterine cavity ,cervix etc. Several variety of medical therapies are available today for its treatment but no treatment promises complete cure and have some short and long term side effects as well, such as conization, cryotherapy and cauterization and antifungal , antibiotics regimens. The long term use of antibiotics lead to various side effects like gastrointestinal upset, nausea vomiting, diarrhea, dizziness and antibiotic resistance may also develop. Therefore search for a safe and effective drug is need of the time especially from herbal treasure. Unani scholars have described principles of treatment for the management of chronic cervicitis and many safe and effective single as well as compound drug drugs in classical Unani literature for the same purpose. In this study , we are planning to use extract form of the Unani polyherbal formulation to evaluate the effectiveness of the this composition of drugs. · · · · |