| CTRI Number |
CTRI/2024/03/064419 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Chronic Cervicitis by Oral administration of Tablet Triphala Guggulu and Yoni Pichu with Darvi Taila |
|
Scientific Title of Study
|
Effect of Triphala Guggulu orally along with Darvi Taila Yoni Pichu in the management of Chronic Cervicitis |
| 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 Anjana M C |
| Designation |
Junior Resident |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7306125464 |
| Fax |
|
| Email |
anjanachandrabose123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishwesh B N |
| Designation |
Professor and Head of Department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8277033135 |
| Fax |
|
| Email |
vishweshbn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishwesh B N |
| Designation |
Professor and Head of Department |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Prasuti Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8277033135 |
| Fax |
|
| Email |
vishweshbn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sundarlal Hospital
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Faculty of Ayurveda Institute of Medical Sciences BHU |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda
IMS BHU
Varanasi |
| 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 Anjana MC |
Sir Sunderlal Hospital BHU |
OPD No 24
Prasuti Tantra OPD
Department of Prasuti Tantra
Faculty of Ayurveda
IMS BHU
Varanasi
UTTAR PRADESH |
7306125464
anjanachandrabose123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N72||Inflammatory disease of cervix uteri. Ayurveda Condition: PARIPLUTA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Charaka Samhita, Procedure details: A sterile cotton swab soaked in medicated oil is kept in vagina for a specific period of time)say for 3 hrs or till the urge for urination.)
(1) Medicine Name: Darvi Taila, Reference: Sahasra Yoga, Route: Vaginal, Dosage Form: Taila, Dose: 15(ml), Frequency: hs, Duration: 10 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala guggulu, Reference: Sharangdhara samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Hot water), Additional Information: -Triphala guggulu contains Hareetaki Vibheetaki Amalaki Pippali and Guggulu |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Only married women of different age group and parity.
2. Patients presenting with at least any 3 of the following clinical signs and symptomatology
of chronic Cervicitis like -
a. Patients presenting with mucopurulent discharge p/v and endocervical bleed.
b. Patients having inflammatory Cervical Pap smear.
c. Patients presenting with clinical features of dyspareunia and cervical tenderness.
d. Patients presenting with clinical features of cervical congestion /strawberry cervix.
e. Patients presenting with intermenstrual/ post coital bleeding.
f. Patients presenting with other symptoms of cervicitis like back ache and lower
abdominal pain. |
|
| ExclusionCriteria |
| Details |
1. Unmarried
2. Pregnant women and Patients suffering from any specific organic lesions such as
Tuberculosis, acute or chronic respiratory diseases, cardiac diseases, renal diseases,
Diabetes mellitus, Hypertension etc.
3. Women with carcinoma of cervix, benign or malignant growth of reproductive tract, any
degree of genital prolapses.
4. Patients having their HIV and VDRL reactive.
16
5. Patients with Cervical Pap smear showing either CIN or papilloma virus infection or
invasive malignancy.
6. Patients having Acute cervicitis.
7. Patients having Acute Pelvic inflammatory disease.
8. Patients with h/o surgery of cervix. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Based on Subjective and Objective criteria and Laboratory investigations
Subjective criteria:
ï‚· Vaginal discharge
ï‚· Post coital bleeding
ï‚· Back ache
ï‚· Inter menstrual spotting
ï‚· Dyspareunia
Objective criteria:
ï‚· Cervical Congestion
ï‚· Cervical discharge
ï‚· Vaginal discharge
ï‚· Cervical tenderness
ï‚· Contact bleeding
Laboratory investigations
ï‚· Positive inflammatory Pap smear
ï‚· Positive endocervical swab culture
ï‚· Colposcopy |
3 Follow ups with equal interval of 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced inflammation ,alleviated symptoms and improved quality of life among study participants |
3 follow ups with Regular interval of 15 days.2 follow ups with medication and 1 follow up without medication |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2024 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anjanachandrabose123@gmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Gynaecological infections are common worldwide. Disease of the cervix are common in almost all sexually active women as cervix is the most common site of genital infection. Cervicitis is an inflammation of the uterine cervix, most often caused by infection. It is a clinical syndrome characterized by the presence of a purulent or muco-purulent discharge that is visible in the endocervical canal or that can be detected with an endocervical smear. Additionally, other clinical signs of inflammation, such as persistent endocervical bleeding (intermenstrual or post-coital vaginal bleeding) which can be induced by the gentle passing of a cotton swab through the endocervix can indicate cervicitis. Although medicines at present are well tolerated by majority of patients and there are no major adverse effects, the search is always going on to explore more effective medicine.Ayurveda considers that all gynecological disorders are caused by vitiation of vata dosha and are mainly described under Yoni vyapada. In present study an attempt has been made to correlate Cervicitis with yoni rogas mentioned in Ayurvedic classics.It is anticipated that the combined effect of Oral Triphala Guggulu administration along with application of Darvi Taila Yoni pichu will demonstrate significant improvements in the management of Chronic Cervicitis. |