| CTRI Number |
CTRI/2024/10/074831 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the efficacy of hingwadi taila basti in management of anovulatory cycles. |
|
Scientific Title of Study
|
Clinical study to evaluate the efficacy of hingwadi taila matrabasti in the management of anovulatory cycle. |
| 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 Snehal Nikas |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9175364968 |
| Fax |
|
| Email |
snehalnikas22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Musale |
| Designation |
Assistant Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9225632451 |
| Fax |
|
| Email |
dr.musale@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Musale |
| Designation |
Assistant Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9225632451 |
| Fax |
|
| Email |
dr.musale@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak ayurved mahavidyalaya and seth tarachand ramnath charitable ayurvedic hospital Rasta peth Pune 11 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Ayurvedic Hospital Rasta Peth |
| Address |
Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune |
| 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 Snehal Nikas |
Tilak Ayurved Mahavidyalaya and seth tarachand ramnath charitable ayurved hospital pune |
OPD no 11 Department of Streeroga and Prasuti Tantra Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
MAHARASHTRA |
9175364968
snehalnikas22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institional Ethics Committee Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Rasta Peth Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament. Ayurveda Condition: ARTAVAVAHA-SROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Matrabasti | (Procedure Reference: Ashtang hriday sutrasthan, Procedure details: Warm hingwadi taila diluted in tila taila inserted from anal opening with the help of glycerin syringe & nozzle)
(1) Medicine Name: Hingwadi taila, Reference: Sharangdhara samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. USG showing anovulation
2. Anovulatory cycles due to PCOS Hypothyroidism obesity.
3. Irregular Mences
4. Dysmenorhea
5. Amenorrhea |
|
| ExclusionCriteria |
| Details |
1. Pitta Pradhan prakruti
2.Sukumar
3. Menorrhagia
4. Patient with anorectal diseases
5 Amenorrhea or oligomenorrhea due to congenital or stuructural anamolies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of hingwadi taila matra basti in managemnet of anovulatory cycles. |
7 days for 3 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regularize cycles with timely ovulation. |
7 days for 3 cycles. |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
18/10/2024 |
| 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
|
Anovulation has been considered as Vata prominent tridoshaj condition. Pathology of this disease takes place at the place of apana vata karya kshetra. Basti is the best treatment for vatajanya vikaar. Hingwadi taila matrabasti is one type of snehabasti which is used in the treatment of aartavkshay as sushrutacharya has explained it as shodana and agneya chikitsa. |