| CTRI Number |
CTRI/2025/06/089222 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [procedure] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of lashuna taila and narayana taila uttarbasti in the treatment of female infertility |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of lashuna taila uttarbasti and narayana taila uttarbasti in the management of stree bandhyattava w.s.r. tubal blockage |
| 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 Gulafshan |
| Designation |
MS(Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic College and Hospital Tulsi |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India 226004
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7905628653 |
| Fax |
0 |
| Email |
khangulafshan80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shashi Sharma |
| Designation |
Professor |
| Affiliation |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India 226004
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8795545443 |
| Fax |
0 |
| Email |
shashi.chd98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulafshan |
| Designation |
MS(Prasuti Tantra Evum Stri Roga) |
| Affiliation |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India 226004
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7905628653 |
| Fax |
0 |
| Email |
khangulafshan80@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India 226004 |
|
|
Primary Sponsor
|
| Name |
State ayurvedic College and Hospital Lucknow |
| Address |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India 226004 |
| 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 Gulafshan |
State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow |
PG Department of Prasuti Tantra Evum Stri Roga State Ayurvedic College and Hospital Tulsidas marg Turiyaganj Lucknow Uttarpradesh India
Lucknow
UTTAR PRADESH |
7905628653
0
khangulafshan80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N701||Chronic salpingitis and oophoritis. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charak samhita Siddhisthan 9, Procedure details: Uttarbasti with Narayana taila
Position- lithotomy position
Frequency-after cessation of menses continue for 3 days for 3 consecutive cycles
Dose-3 to 5 ml once a day
Route of administration- Intrauterine(vaginal)
Procedure:
purvakarma- Snehana with Vatashamak Tail on the lower abdomen, back, & lower limbs followed by swedana specially baluka sweda
Examination of pulse & blood pressure will be done.
Pradhan karma-1.The genital parts will be cleaned with any antiseptic solution. 2.The vagina & cervix will be visualized with the help of the Sims speculum & anterior vaginal wall retractor. 3.The anterior lip of the cervix will be held with the help of vulsellum forcep. 4.Uterine sounding will be done & then Uttarbasti cannula, already attached with 5 mL syringe filled with Narayana Taila will be passed into the uterine cavity after making a head low position. 5.The drug will be pushed above the level of the internal os with constant force. 6.Pichu will be placed in vagina. The patient will be sent to bed.
Pashchat karma-Patient will be kept in head low position for 1½ hours. Pulse & blood pressure will be watched. Pichu will be removed after 2 hours.)
| | 2 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charak samhita Siddhisthan 9, Procedure details: Uttarbasti with Lashuna taila
Position- lithotomy position
Frequency-after cessation of menses continue for 3 days for 3 consecutive cycles
Dose-3 to 5 ml once a day
Route of administration- Intrauterine(vaginal)
Procedure:
purvakarma- Snehana with Vatashamak Tail on the lower abdomen, back, & lower limbs followed by swedana specially baluka sweda
Examination of pulse & blood pressure will be done.
Pradhan karma-1.The genital parts will be cleaned with any antiseptic solution. 2.The vagina & cervix will be visualized with the help of the Sims speculum & anterior vaginal wall retractor. 3.The anterior lip of the cervix will be held with the help of vulsellum forcep. 4.Uterine sounding will be done & then Uttarbasti cannula, already attached with 5 mL syringe filled with Lashuna Taila will be passed into the uterine cavity after making a head low position. 5.The drug will be pushed above the level of the internal os with constant force. 6.Pichu will be placed in vagina. The patient will be sent to bed.
Pashchat karma-Patient will be kept in head low position for 1½ hours. Pulse & blood pressure will be watched. Pichu will be removed after 2 hours.)
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Married women with Age between 21 to 40 years.
2.Patient of primary and secondary infertility
3.Clinically diagnosed Patients of unilateral or bilateral tubal blockage.
|
|
| ExclusionCriteria |
| Details |
1.Patient with active and chronic pelvic infections.
2.Patient of any Genital organ diseases like- Uterine fibroid. Genital Prolapse Endometriosis, Adenomyosis etc.
3.Patient with history of hypdrosalpinx.
4.Women of age less than 21 and above than 40.
5.Other systemic disorders like hypertension, diabetes, tuberculosis.
6.Patient having any congenital anomalies of uterus.
7.Patient having organic pathology of uterus and adnexal like cervical carcinoma, Cervical Intraepithelial Neoplasia (CIN). And any malignant growth.
8.HIV, VDRL, HBsAg positive patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to evaluate the efficacy of lashuna taila and narayana taila uttarbasti in management of tubal blockage
Improvement in tubal patency
|
after 30 days
after 30 days
after 30 days
after 30 days of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Conception / pregnancy rate
Reduction in associated symptoms of bandhayyatava |
after30 days
after 30 days
aftes 30 days
after completion of trial |
|
|
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)
|
25/06/2025 |
| 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="1"
Months="5"
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
|
this is a randomised comparative clinical study phase 2 parallel group trial . Comparing the efficacy of Lashuna taila uttarbasti and Narayana taila uttarbasti in case of stri bandhyattava for 3 months in 30 patients . The patient fulfilling the cclinical criteria for diagnosis of stri bandhyattava will be randomly selected from OPD / IPD of State Ayurvedic College and Hospital Lucknow and referred cases from other hospitals . a careful history , physical examination and necessary investigations will be performed . further patients divided into two groups , Group A- patient will be treated with Lashuna taila uttarbasti in the dose 3-5 ml through transvaginal route after cessation of menses for 3 alternative days for 3 consecutive cycles in Group B - patient will be treated with Narayana taila uttarbasti in the dose of 3- 5 ml through transvaginal route after cessation of menses for 3 alternative days for 3 concsecative cycles . Follow up period after 30 days with trial drug and last follow up after 30 days of completion of trial. |