CTRI

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CTRI Number

CTRI/2026/02/104094 [Registered on: 17/02/2026] Trial Registered Prospectively

Last Modified On:

16/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study to compare Kashmaryadi medicated ghee taken by mouth and Uttar Basti therapy for treating female infertility, especially in women who are not releasing eggs properly or whose fallopian tubes are blocked.

Scientific Title of Study

A Clinical comparative Evaluation of the Efficacy of Kashmaryadi Ghritapaan and Uttarbasti in the Managment of Stree Bandhyattava With Special Reference to Anovulation and Tubal Blockage.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	DrMonika Joshi
Designation	MS Scholar
Affiliation	State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow
Address	P.G Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow UTTAR PRADESH 226004 India P.G Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow UTTAR PRADESH 226004 India Lucknow UTTAR PRADESH 226004 India
Phone	9140898131
Fax	0
Email	joshimohini51@gmail.com

Details of Contact Person
Scientific Query

Name	ProfShashi Sharma
Designation	Professor
Affiliation	State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow
Address	P.G Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow UTTAR PRADESH 226004 India P.G Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow UTTAR PRADESH 226004 India Lucknow UTTAR PRADESH 226004 India
Phone	8795545443
Fax	0
Email	shashi.chd98@gmail.com

Details of Contact Person
Public Query

Name	ProfShashi Sharma
Designation	Professor
Affiliation	State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow
Address	P.G Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow UTTAR PRADESH 226004 India P.G Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow UTTAR PRADESH 226004 India Lucknow UTTAR PRADESH 226004 India
Phone	8795545443
Fax	0
Email	shashi.chd98@gmail.com

Source of Monetary or Material Support

State Ayurvedic College and hospital, Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh 226004, India

Primary Sponsor

Name	State Ayurvedic College and hospital,Lucknow
Address	State Ayurvedic College and hospital, Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh 226004, India
Type of Sponsor	Government medical college

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
DrMonika Joshi	State Ayurvedic College And Hospital, Lucknow	OPD No.07 P.G Department of Prasuti Tantra Evum Stree Roga, State Ayurvedic College and Hospital Tulsidas Marg Old Haider Ganj Turiyaganj,Lucknow UTTAR PRADESH 226004 India. Lucknow UTTAR PRADESH	09140898131 0 joshimohini51@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

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:O268\|\|Other specified pregnancy relatedconditions. Ayurveda Condition: VANDHYA,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Kashmaryadi Ghritapaan, Reference: charak chikitsa , Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
2	Comparator Arm	Procedure	-	uttara-bastiH, उत्तर-बस्तिः	(Procedure Reference: charak siddhisthaan, Procedure details: Procedure Name- Uttar Basti Reference of procedure - charak siddhistaan Pradhan karma -The genital parts will be cleaned with antiseptic solution. The vagina and cervix will be visualized with the help of the Sims speculum andan anterior vaginal wall retractor. The anterior lip of the cervix will be held with the help of vulsellum forcep. Uterine sounding will be done and then Uttarbasti cannula, already attached with 5 mL syringe filled with Kashmaryadi Ghrita will be passed into the uterine cavity after making a head low position. The drug will be pushed above the level of the internal os with constant force. Pichu will be placed in vagina.The patient will be sent to bed.Pashchat karma –Patient will be kept in head low position for half hours. Pulse and blood pressure will be watched. Pichu will be removed after 2 hours.For 3 consecutive daysFor 3 consecutive cycles) (1) Medicine Name: Kashmaryadi Ghrita, Reference: charak chikitsa, Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Days

Inclusion Criteria

Age From	23.00 Year(s)
Age To	40.00 Year(s)
Gender	Female
Details	1.Married women with Age between 23 to 40 years. 2.Diagnosed or Undiagnosed Patient of primary and secondary infertility. 3.Patients having Hormonal imbalance related of Ovulatory Dysfunction (Anovulation). 4.Patients of partial, unilateral or bilateral tubal blockage.

ExclusionCriteria

Details

1.Age below 23 and above 40 years.
2.Patients having any systemic disorders like Hypertension, Diabetes etc.
3.Patient with congenital and structural uterine abnormalities like fibroid polyps, endometriosis, adenomyosis etc.
4.Patients taking oral contraceptive pills. 5.Patients coming with delayed menstrual cycle of more than three months.

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
1.To compare the efficacy of Kashmaryadi Ghritapaan and Kashmaryadi Ghrita Uttarbasti in management of Stree Bandhyattava with special reference to Anovulation and Tubal Blockage. 2.To study etiopathogenesis of Stree Bandhyattava especially on anovulation and Tubal Blockage.	3 Follow up with trial drug and 1 Follow up without trial drug. 1) 1st Follow up- After completion of 1st menstrual cycle 2) 2nd Follow up-After completion of 2nd menstrual cycle 3) 3rd Follow up-After completion of 3rd menstrual cycle 4) 4th Follow up-After completion of 4th menstrual cycle

Secondary Outcome

Outcome	TimePoints
1.To provide cost effective, easily available comparatively safe and effective treatment for infertile female patient. 2.To study the complications of trial drug if any during and after the clinical trial.	3 Follow up with trial drug and 1 Follow up without trial drug. 1) 1st Follow up- After completion of 1st menstrual cycle 2) 2nd Follow up-After completion of 2nd menstrual cycle 3) 3rd Follow up-After completion of 3rd menstrual cycle 4) 4th Follow up-After completion of 4th menstrual cycle

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 2

Date of First Enrollment (India)

01/04/2026

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="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 Kashmaryadi Ghritapaan and Uttarbasti in the management of Stree Bandhyattava for 3 months in 40 patients. The patient fulfilling the clinical

criteria for diagnosis of Stree Bandhyattava will be randomly selected from OPD and IPD of state Ayurvedic College and Hospital, Lucknow and referred cases from other hospitals. A careful history, physical examination and necessary investigation will be performed. Further patient divided into two groups, Group-A- In this group patients will be treated with Kashmaryadi Ghritapaan orally 10 ml BD empty stomach with lukewarm water for the period of 3 months. Group-B- In this group patients will be treated with Kashmaryadi Ghritapaan orally 10 ml BD empty stomach with lukewarm water for the period of 3 months along with Kashmaryadi Ghrita Uttar basti of 3-5 ml by inter uterine route for the period of 3 days after the clearance of menses. Follow up period will be 30 days after the completion of trial.