| CTRI Number |
CTRI/2025/07/091624 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Prabhav of apamarga kshara and jatyadi tail pichu in garbhashaygata Disease |
|
Scientific Title of Study
|
To evaluate the efficacy of Apamarga Kshara and Jatyadi Taila Pichu in Cervical Erosion |
| 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 Saloni Devi |
| Designation |
P G Scholar |
| Affiliation |
S. G. M. P. G. Ayurvedic College and Hospital |
| Address |
Department of Prasuti evam Stri Rog Saheri Nandgunj
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
6307194660 |
| Fax |
|
| Email |
Salonigupta987sg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendra Kumar Patel |
| Designation |
Professor |
| Affiliation |
S G M P G Ayurvedic College and Hospital |
| Address |
Head of Department Prasuti evam Stri Rog Ground Floor Saheri Nundgunj
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9415970999 |
| Fax |
|
| Email |
drshyamlal80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saloni Devi |
| Designation |
P G Scholar |
| Affiliation |
S G M P G AYURVEDIC COLLEGE AND HOSPITAL |
| Address |
Department of Prasuti evam Stri Rog Saheri Nandgunj
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
6307194660 |
| Fax |
|
| Email |
Salonigupta987sg@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G M P G Ayurvedic College and Hospital Saheri Ghazipur Uttar Pradesh 233302 |
|
|
Primary Sponsor
|
| Name |
Dr Saloni Devi |
| Address |
Department of Prasuti evam Stri Rog Saheri Nandgunj Ghazipur Uttar Pradesh 233302 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Saloni Devi |
S. G. M. P. G. Ayurvedic College and Hospital |
OPD and IPD Department of Prasuti evam Stri Rog Saheri Nandgunj
Ghazipur
UTTAR PRADESH |
6307194660
Salonigupta987sg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC S.G.M.P.G. Ayurvedic College Saheri Ghazipur Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: APAMARGA KSHARA, Reference: RASA TARANGINI, Route: Topical, Dosage Form: Kshara , Dose: 00(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: JATYADI TAIL, Reference: SHARAGDHAR SAMHITA, Route: Vaginal, Dosage Form: Taila, Dose: 00(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Only married women of different age group & parity.
Patients must having erosion on their cervix.
|
|
| ExclusionCriteria |
| Details |
Unmarried
2. 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 prolapse, PCOD, hypoplastic uterus, any congenital abnormality of genital tract.
4. Severe anaemic patients (Hb less than 7gm%).
5. Patients having their VDRL reactive.
6. Patients with cervical Pap smear showing either CIN or papilloma virus infection or invasive malignancy.
7. Patients with pregnancy history of recent delivery of three month or taking OCPs.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Finally the treatment will be assessed on the basis of following criteria of improvement of symptoms and sign i.e. erosion, which will based on Ayurveda and Modern science.
(1) Improvement in the findings.
(2) Reduction in the discharge.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Routine Examinations
a. Blood : Hb% (In gram % by Shahli’s method)
TLC (By Neubar’s method)
DLC (By Neubar’s method)
ESR (By Westergren method)
FBS
Blood urea
VDRL
b. Urine : Routine and Microscopic.
Specific examination
These were to know vaginal infection, cytology and to exclude malignancy.
|
8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/08/2025 |
| 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="2"
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
|
The whole research work will be summarized and
conclusion will be made on the basis of the observation which will be done on
the subjective and objective parameters |