CTRI

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CTRI Number

CTRI/2026/01/101042 [Registered on: 14/01/2026] Trial Registered Prospectively

Last Modified On:

14/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Ayurvedic treatment of tubal blockage through uttarbasti with lashun taila

Scientific Title of Study

A controlled clinical study to evaluate the effect of Lashuntaila over Kumaritaila uttarabasti in the management of vandhytwa w.s.r to 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	DrDharmi kamleshkumar raval
Designation	PG Schloar
Affiliation	shree jagadguru gavisiddheshwara ayurvedic medical college koppal
Address	OPD No. 17,Deptartment of prasooti tanyra and stree roga , shree jagadguru gavisiddheshwara ayurvedic medical college koppal Koppal KARNATAKA 583231 India
Phone	7359759784
Fax
Email	dharmiraval2201@gmail.com

Details of Contact Person
Scientific Query

Name	DrNiveditha somalapur
Designation	Associate professor and Guide
Affiliation	shree jagadguru gavisiddheshwara ayurvedic medical college koppal
Address	OPD No. 17,Deptartment of prasooti tanyra and stree roga , shree jagadguru gavisiddheshwara ayurvedic medical college koppal Koppal KARNATAKA 583231 India
Phone	9886800413
Fax
Email	nivedita.somalapur@gmail.com

Details of Contact Person
Public Query

Name	DrNiveditha somalapur
Designation	Associate professor and Guide
Affiliation	shree jagadguru gavisiddheshwara ayurvedic medical college koppal
Address	OPD No. 17,Deptartment of prasooti tanyra and stree roga , shree jagadguru gavisiddheshwara ayurvedic medical college koppal Koppal KARNATAKA 583231 India
Phone	9886800413
Fax
Email	nivedita.somalapur@gmail.com

Source of Monetary or Material Support

shree jagadguru gavisiddheshwara ayurvedic medical college and hospital,koppal

Primary Sponsor

Name	Dr Dharmi raval
Address	Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital,koppal
Type of Sponsor	Other [SELF]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Dharmi Raval	shree jagadguru gavisiddheshwara ayurvedic medical college koppal	shree jagadguru gavisiddheshwara ayurvedic medical college koppal Koppal KARNATAKA	7359759784 dharmiraval2201@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTEE,SJGAMC,KOPPAL	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N971\|\|Female infertility of tubal origin. Ayurveda Condition: VANDHYA,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: kumari taila, Reference: Srikantha Murthy KR. Vol. 2. Varanasi: Krishnadasa Academy; 2002. Bhavaprakasha of Bhavamishra; pp. 680– 62/42-48., Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: lasun taila, Reference: kashyapsamhita kalpa sthana 2, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	20.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	1.Woman diagnosed with Tubal blockage. 2.Both the patients having primary & secondary 3.female infertility included. Patients between age group of 20 to 45 year

ExclusionCriteria

Details

1.Patients having any urogenital infection were excluded from study. (PID, Pelvic
tuberculosis, more etc.)
2.Patients suffering from any chronic debilitating disease like STD, Hepatitis B, Contagious
disease etc. were also excluded from the study.
3.Patients having any congenital anomalies of uterus, ovaries and fallopian tubes were
excluded from the study.
4.Patients having Uterine fibroids [subserosal & submucosal] more than 3cm

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
clear the tubal blockage	clear the tubal blockage

Secondary Outcome

Outcome	TimePoints
she will be able to concieve	after 3 month

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 3

Date of First Enrollment (India)

28/01/2026

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="0"
Months="7"
Days="10"

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

Since the beginning of time human infertility has been a source of personal misery. Infertility is inability to conceive within one or more years of regular unprotected coitus.

Around 17.5 percentage of the adult population roughly 1 in 6 worldwide experience infertility, showing the urgent need to increase access to affordable, high-quality fertility care. According to modern science, there are 5 main factors responsible for infertility i.e.

Tubal disease (25 to 30 percentage)

Ovulatory dysfunction (30 to 40 percentage)

Uterine factor (10 percentage)

Cervical factor (5 percentage)

Pelvic endometriosis (1to 10 percentage)

Tubal factor as the causes of female infertility which includes; Peritubal adhesions, Endosalpingeal damage, Salpingitis isthemica nodosa, Tubal endometriosis, Tubal spasm,

Polyps/Mucous debris with tubal lumen, Previous tubal surgery or sterilization. In modern science, there are surgeries like Tubal microsurgery, Laparoscopic tubal adhesiolysis, Fimbrioplasty and tubal surgery, Tubal cannulation etc for the tubal blockage but these modalities have their own demerits. so, directly they refer to IVF. The chief among the

adverse effect is failure of surgery and high incidence of ectopic pregnancy in post treatment cases. There failure rate is more than success rate. So, it is great scope of research to find out safe, potent, cost-effective treatment from ayurveda for the management of tubal blockage. In Ayurvedic classics, there are so many factors described which are essential for fertility, out of which Acharya Sushrut has described 4 factors i.e. Rutu, Kshetra, Ambu, Beeja. Among these 4, Kshetra factor has prime role i.e., the female reproductive system.

In present era, Vandhytwa has been one of the unsolved major complaints of women hood. Acharya Kashyapa in Kashyapa Samhita have mentioned about the lashuna born from nectar and it is rasayana (rejuvenating). The breasts of women never fall (become lax) by daily use of lashuna, neither their beauty nor progeny and strength or longevity decreases. Their fortune increases and youth becomes stable. We can corelate Tubal blockage with Srotosanga, as to clear the Srotosanga we can use Ushna, Tikshna dravyas.

In present study, Lashun taila mentioned in Kashyap Samhita for the treatment of vandhytwa containing lashun is selected having Ushana, Tikshna, Rasayana, Vata-kaphahara,

Vrsya properties. By the virtue of Tikshna Ushna gunas of Lashun srotosanga can be relieved. Acharya Sushruta has considered Tila Taila as Yonishula Prashamana & Garbhashayashodhana. It is Sara, Vyavayi, Vikasi, Krimighna & Vranaghna. All these Gunas make it a suitable medium, as it may itself act to open the blockage. Its Vyavayi, Vikasi & Sara Guna may improve the availability of drugs on target organs. So, these properties may be helpful to clear the tubal blockage.Hence, the present study is taken up to evaluate the effect of Lashun taila in Tubal blockage.