| CTRI Number |
CTRI/2023/08/056761 [Registered on: 22/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study of Brihtyadi Ghan vati and laghu panchmoola kwath prakshalan and taila pichu in paripluta yonivyapad wsr PID |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Brihtyadi Ghan vati with Laghu Panchmoola kwath prakshalan and taila pichu in Paripluta Yonivyapad wsr PID |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruby Gupta |
| Designation |
PG scholar in prasuti tantra & stri rog |
| Affiliation |
State Ayurvedic college and hospital Lucknow UP |
| Address |
Department of prasuti tantra & stri rog
State Ayurvedic college and hospital Lucknow UP
Tulsidas Marg Turiyaganj Lucknow
Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7691919450 |
| Fax |
|
| Email |
rubyg3142@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJaya Srivastava |
| Designation |
MD PhD lecturer PG Department of Prasuti tantra and Stri Rog |
| Affiliation |
State Ayurvedic college and hospital Lucknow UP |
| Address |
Department of prasuti tantra & stri rog
State Ayurvedic college and hospital Lucknow UP
Tulsidas Marg Turiyaganj Lucknow
Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9838436080 |
| Fax |
|
| Email |
jayasrivas541@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJaya Srivastava |
| Designation |
MD PhD lecturer PG Department of Prasuti tantra and Stri Rog |
| Affiliation |
State Ayurvedic college and hospital Lucknow UP |
| Address |
Department of prasuti tantra & stri rog
State Ayurvedic college and hospital Lucknow UP
Tulsidas Marg Turiyaganj Lucknow
Uttar Pradesh
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9838436080 |
| Fax |
|
| Email |
jayasrivas541@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic college and hospital Tulsidas Marg Turiyaganj Lucknow 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic college and hospital Lucknow UP |
| Address |
State Ayurvedic college and hospital Tulsidas Marg Turiyaganj Lucknow UP 226004 |
| 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 |
| DrRuby Gupta |
State Ayurvedic college and hospital Lucknow |
OPD NO.1
Department of Prasuti tantra and Stri Rog
State Ayurvedic college and hospital Tulsidas Marg Turiyaganj Lucknow
Lucknow
UTTAR PRADESH |
7691919450
rubyg3142@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethic commitee State Ayurvedic college and hospital Lucknow |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N739||Female pelvic inflammatory disease, unspecified. Ayurveda Condition: Paripluta Yonivyapad, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brihtyadi Ghan Vati, Reference: Sushrut samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: After clearness of menses ( 3 consecutive cycle) | | 2 | Comparator Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Sushrut samhita, Procedure details: 7 day after clearness of menses for 3 consecutive cycle )
(1) Medicine Name: Laghu panchmoola kwath, Reference: Sushrut samhita, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 7 Days | | 3 | Comparator Arm | Procedure | - | Yoni pichu | (Procedure Reference: Sushrut samhita, Procedure details: 7day after clearness of menses for 3 consecutive cycle)
(1) Medicine Name: Laghu panchmoola taila, Reference: Sushrut samhita, Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1• Patient willing for trial.
2• Married women
3• lower abdomen pain
4• Low back pain.
5• Abnormal cervical or vaginal discharge
6• Dyspareunia |
|
| ExclusionCriteria |
| Details |
1• Pregnant women
2• Unmarried
3• PID associated with prolapsed uterus.
4• Endometriosis/ Chocolate cyst.
5• Severe or chronic ill health condition like diabetes mellitus & Hypertension tuberculosis
etc.
6• Acute PID & peritonitis, tubo- Ovarian abscess, Genital tumor & malignancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess the efficacy of Brihatyadi Ghan vati and Laghu Panchmula kwath prakshalan
with taila pichu in management of Paripluta Yonivyapad
2)To assess the efficacy of trial therapy on
subjective parameters like pain in lower abdomen low back pain vaginal discharge dyspareunia objective criteria like cervical motion tenderness fornix tenderness |
Final assessment will be done after completion
of trial of 4 consecutive months (3 months with
clinical therapy and 1 month drug free) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of trial therapy on
subjective parameters like pain in lower abdomen low back pain vaginal discharge dyspareunia objective criteria like cervical motion tenderness fornix tenderness USG finding ( fluid in pouch of Douglas) |
Follow up- Three follow up will be done at every 1month during the therapy |
|
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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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is entitled as" A comparative clinical study to evaluate the effect of brihtyadi Ghan vati with laghu panchmoola kwath prakshalan and taila pichu in paripluta yonivyapad w.s.r PID Objective of study- To compare the effect of brihtyadi Ghan vati with laghu panchmoola kwath prakshalan and Brihtyadi Ghan vati with laghu panchmoola kwath prakshalan along with laghu panchmoola taila pichu in management of paripluta yonivyapad w.s.r PID
Type of study-Randomised comparative parallel open clinical trial Administration of trail therapy- Minimum 40 patients having cardinal symptoms of paripluta yonivyapad Group allocation- Registered patients will be randomly divided into two groups
Group A-Brihtyadi Ghan vati 2 BD (500mg) with water for 21 day and laghu panchmoola kwath prakshalan for 7 day (after clearness of menses)
Group B- Brihtyadi Ghan vati 2 BD ( 500mg) with water and laghu panchmoola kwath prakshalan along with laghu panchmoola taila pichu for 7 day (after clearness of menses)
Duration of trail- 3 consecutive cycle Follow up during treatment- 3 follow up will be done at every 1month during the therapy Follow up after the treatment- fourth follow up will be done after 1month of the completion of the trail ( without medicine)
Criteria for the selection patients Diagnostic criteria- 1.Lower abdomen pain 2.Low back pain 3.Abnormal vaginal discharge 4.Dyspareunia 5.Cervical motion tenderness or adnexal/Fornix tenderness 6.USG report having suggestive finding PID When 3 and more criteria is fulfilled that it’s said to patients of PID Assessment criteria-
Subjective criteria- •Sparshakshama (Tenderness) •Vedna in shroni vankshan ( pain in lower abdomen) •Prishtvedna (low back pain •Yoni srava( vaginal discharge) •Gramyadharmaruja ( Dyspareunia)
Objective criteria •Cervical motion tenderness •Adnexal/ Fornix tenderness •USG finding ( fluid in pouch of Douglas)
Investigation- •CBC •ESR •RBS •LFT •KFT •Urine examination R/M •USG pelvis (lower abdomen)/TVS |