| CTRI Number |
CTRI/2024/07/071280 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Gokshuradi Guggulu With Musta Panaka as Anupana and Lodhra Vata Twaka Kashaya Yoni Prakshalana in Abnormal vaginal Discharge |
|
Scientific Title of Study
|
Effect of Gokshuradi Guggulu With Musta Panaka as Anupana and Lodhra Vata Twaka Kashaya Yoni Prakshalana in Abnormal vaginal Discharge |
| 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 Savaliya Komalben Ashokbhai |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College and Hospital |
| Address |
Department of Prasutitantra evum Stree Roga, Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura, Ernakulam, Kerala, INDIA
Ernakulam
KERALA
682301
India |
| Phone |
9067783294 |
| Fax |
|
| Email |
dr.komal1911@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College and Hospital |
| Address |
Department of Prasutitantra evum Stree Roga, Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura, Ernakulam, Kerala, INDIA
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College and Hospital |
| Address |
Department of Prasutitantra evum Stree Roga, Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura, Ernakulam, Kerala, INDIA
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital, Tripunithura, Ernakulam, Kerala |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College and Hospital Tripunithura |
| Address |
Department of Prasutitantra Evum Stree Roga, Government Ayurveda College and Hospital, Puthiyakavu, Dhanwantari Nagar, Tripunithura-682301, Ernakulam, Kerala, India |
| 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 Savaliya Komalben Ashokabhai |
Government Ayurveda college and Hospital Tripunithura |
Department of Prasutitantra Evum Stree Roga Government Ayurveda College and Hospital Dhanwantari Nagar Puthiyakavu Tripounithura-682301 Ernakulam Kerala
Ernakulam
KERALA |
9067783294
dr.komal1911@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL COMMITTEE FOR ETHICS IN RESEARCH Govt Ayurveda College Tripunithura Kochi Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Guggulu, Reference: Sharangdhara Samhita Madhyama Khand vati Kalpana 7/84-87, Route: Oral, Dosage Form: Guggulu , Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Musta Panaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients complaining of abnormal vaginal discharge as cardinal symptom. |
|
| ExclusionCriteria |
| Details |
1. Post-menopausal women
2. Pregnant and lactating women
3. Any type of malignancy
4. Patient having STDs.
5. Patient with uncontrolled diabetes mellitus
6. Known case of any organic pathology of reproductive organs with cervical polyp and cervical or vaginal cancer.
7. Any discharge contaminated with urine or faecal matter |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the amount of Abnormal Vaginal Discharge on basis of the Likert scale and Scoring Pattern |
0th day, 31st day, 61st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of oral administration of gokshuradi guggulu with musta panaka as anupana lodhra vata twak kashaya yoni prakshalana in colour, consistency, smell, itching and burning sensation of abnormal vaginal discharge |
Patients will be assessed on basis of scoring pattern on 0th day, 31st day and 61st day |
| To Evaluate the Change in Vaginal swab culture & Vaginal pH |
0th day, 31st day, 61st day |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="6"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Abnormal vaginal discharge is one of the most frequent causes of the doctor visit. Which affect day by day quality of women life.
If not treated correctly & timely it may lead to complications like PID, scarring of oviducts, adhesions, premature labor and delivery in pregnant women, spreading of infection to nearby organs like liver.
Early recurrence of symptoms is major drawbacks of present antibiotics or antifungal treatments.
To find out the safe, efficacious, cost-effective treatment modality in Ayurveda ensuring improvement in symptoms along with maintaining natural fauna of vagina.
Both Abhyantara and Bahya/Sthaanika chikitsa are being applied to target the disease at its site of origin as well as at its site of manifestation. Gokshuradi Guggulu, mentioned in Sharangadhara Samhita Madhyama Khanda in vati kalpana chapter and Lodhra Vata Twak Kashaya, mentioned in Ashtang Sangraha Uttarasthaana Guhyaroga pratishedha are taken. Gokshuradi Guggulu, Musta panaka and Lodhra Vata twak Kashaya Yoga have been selected for the present study because of its Tridoshashamaka, ruksha, kashaya, grahi, kledahara, stambhaka, krimighna and kandughna properties. The majority of the formulation’s components include antifungal, antibacterial, antimicrobial, and anti-inflammatory activities. The oral administration of Gokshuradi Guggulu with Musta panaka as Anupana and Yoni Prakshalana of Lodhra Vata Twak Kashya is therefore, expected to be a very potent combination against Abnormal Vaginal Discharge. The study will be conducted following GCP regulations, AYUSII guidelines and taking suggestions from scientific and ethics committees. |