| CTRI Number |
CTRI/2022/09/045753 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Uttar Basti and Pratimarsh Nasya] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Uttar Basti and Pratimarsh Nasya with Shatpushpa Tail in the management of Stree Bandhyattava w.s.r. to Tubal Blockage and Anovulation. |
|
Scientific Title of Study
|
"A clinical study to evaluate the efficacy of Uttar Basti and Pratimarsh Nasya with Shatpushpa Tail in the management of Stree Bandhyattava w.s.r. to Tubal Blockage and Anovulation." |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Piyusha Pandey |
| Designation |
PG Scholar Prasuti Tantra and Stri Rog |
| Affiliation |
State Ayurvedic College and Hospital Lucknow UP |
| Address |
State Ayurvedic College and Hospital Lucknow UP
Department of Prasuti Tantra and Stri Rog State Ayurvedic College and Hospital Tulsidas Marg Tudiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8874081065 |
| Fax |
|
| Email |
piyushapandey26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Sharma |
| Designation |
MS Ayu Lecturer PG Department of Prasuti Tantra and Stri Rog |
| Affiliation |
State Ayurvedic College and Hospital Lucknow UP |
| Address |
State Ayurvedic College and Hospital Lucknow UP
Department of Prasuti Tantra and Stri Rog State Ayurvedic College and Hospital Tulsidas Marg Turiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8743976379 |
| Fax |
|
| Email |
drshikhasharma1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Sharma |
| Designation |
MS Ayu Lecturer PG Department of Prasuti Tantra and Stri Rog |
| Affiliation |
State Ayurvedic College and Hospital Lucknow UP |
| Address |
State Ayurvedic College and Hospital Lucknow UP
Department of Prasuti Tantra and Stri Rog State Ayurvedic College and Hospital Tulsidas Marg Turiyaganj Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8743976379 |
| Fax |
|
| Email |
drshikhasharma1982@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital Tulsidas Marg Turiyaganj Lucknow UP Pin code 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and Hospital Tulsidas Marg Turiyaganj Lucknow UP |
| 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 Piyusha pandey |
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 UP
Lucknow
UTTAR PRADESH |
8874081065
piyushapandey26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Member secretary State Ayurvedic College & Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N971||Female infertility of tubal origin. Ayurveda Condition: Stree Bandhyattava wsr Tubal Blockage and Anovulation, (2) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: Stree Bandhyattava wsr Tubal Blockage and Anovulation, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, पà¥à¤°à¤¤à¤¿à¤®à¤°à¥à¤¶ | (Procedure Reference: Charak samhita, Procedure details: Procedure reference- Charak Samhita
Procedure Details- Pratimarsh nasya- Purva karma- urdhvajatrugata sukshma snehana and swedana Pradhana karma- 2 drops of medicated oil will be given in each nostril Pashchata karma- rest for 10 minute)
(1) Medicine Name: Shatpushpa , Reference: Kashyap samhita, Route: Nasal, Dosage Form: Taila, Dose: 2 drops in each nostrils, Frequency: BID, Duration: 3 Months
)
(1) Medicine Name: Shatpushpa, Reference: Kashyap Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 3 Months | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shapushpa, Reference: Kashyap samhita 5/25, Route: Vaginal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -after clearance of menses -uttar basti will be given for 3 days for 3 consecutive cycle(2) Medicine Name: Shatpushpa, Reference: Kashyap samhita, Route: Oral, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: This procedure will be done after clearance of menses for 3 months | | 3 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Samhita, Procedure details: Procedure refrence- Charak samhita Procedure Details- Uttar Basti karma- purva karma- adhonabhigat abhyanga and swedana ,Pradhana karma- patient will be in lithotomy position 3 ml lukewarm medicated oil will be instilled slowly in intrauterine cavity. Pashchata karma- 30 minutes rest in head low position.
(1) Medicine Name: Shatpushpa , Reference: Kashyap samhita, Route: Vaginal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 3 Days
)
(1) Medicine Name: Shatpushpa, Reference: Kashyap Samhita, Route: Vaginal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 3 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
1) Age between 20 to 40 years
2) Patient coming with primary and secondary infertility
3) Patient coming with unilateral/ bilateral/ partial tubal blockage
4) Patient coming with complaints of Ovulatory Dysfunction as per follicular
study |
|
| ExclusionCriteria |
| Details |
1) Age below 20 and above 42 years
2) Patient coming with menstrual disorders like- menorrhagia, menometrorrhagia, secondary amenorrhoea of more than three months
3) Patient coming with acute inflammatory/ infectious state of genital organs like- PID, Endometriosis, genital tuberculosis, genital prolapse etc.
4) Patient coming with complaints of infertility with cervical/ vaginal/ unknown factor
5) Any congenital anomalies of genital organ
6) Patient suffering with any Systemic/ Acute illness
7) Any significant abnormality found in Husbands seminogram |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of trial therapy on subjective criteria like abnormalities in menstrual cycle - duration, interval, amount of bleeding , pain, and other associated symptom like stress and insomnia.
And on Objective criteria-
Conception , Tubal patency, Ovulation, Endometrial thickness. |
Final assessment will be done after completion of trial of 6 Months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome will be done on the basis of changes seen in subjective and objective criteria |
six months |
|
|
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)
|
23/09/2022 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
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 “A clinical study to evaluate the efficacy of ‘Uttar basti’ & ’ Pratimarsh nasya’ with ‘Shatpushpa tail’ in the management of ‘Stree bandhyattva’ w.s.r. Tubal blockage & Anovulationâ€. Objective- To evaluate the efficacy of ‘Uttar Basti’ and ‘Pratimarsh Nasya’ with ‘Shatpushpa tail’ in the management of ‘Stree Bandhyattava’ and gauging the improvement in causative factor (Tubal blockage & Anovulation) mainly responsible for female infertility.• To assess the conceiving rate during trial and follow up. Type of Study:- A Randomized open level parallel groups clinical trial. Period of Study:- 6 Consecutive cycles ( 3 consecutive cycles with medication & 3 consecutive cycles with out medication). Follow up period:- During trial- 2 follow ups After trial- 3 follow ups Sample size:- Minimum 30 patients will be registered. Grouping of Patients:- Group A- Minimum 15 patients of Tubal blockage . Group B- Minimum 15 patients of Anovulation . Both group will be treated with same trial drug ‘Shatpushpa tail’ in the form of‘Uttar basti’ & ‘Pratimarsh nasya’. Inclusion criteria:- • Age between 20 to 42 years .• Patient coming with primary and secondary infertility • Patients coming with unilateral/ bilateral/ partial tubal blockage. • Patients coming with Complaints of Ovulatory Dysfunction (as per Follicular study). Exclusion criteria:- • Age below 20 and above 42 years.• Patients coming with menstrual disorders like- Menorrhagia, Menometrorrhagia, Secondary Amenorrhea of more than three months.• Patient coming with acute inflammatory/ infectious state of Genital Organs like- PID, Endometriosis, Genital tuberculosis, Genital Prolapse, etc. • Patient coming with Complaints of infertility with Cervical / Vaginal /Unknown factor. • Any congenital anomalies of Genital Organ.• Patient suffering with any Systemic/ Acute illness • Any significant abnormality found in Husband’s Seminogram. Diagnostic criteria:- HSG (for Tubal blockage) TVS (for Follicular Study) Clinical Procedure:- It will be executed in minor OT of Prasuti Tantra and Stri Roga Department of State Ayurvedic College, Lucknow. Drug, Dose and Duration ( In each cycle ):- For adhonabhigat Snehana and swedana: ‘Shatpushpa tail’ / ‘Dashmool kwath’ (5 days) For ‘Anuvasana Basti’: ‘Shatpushpa tail’ -60 ml (two times) For ‘Asthapana Basti’: Madhu, Saindhava lavan, Shatpushpa tail, Shatpushpa kalka, Dashmool kwath - 700 ml (one times) For ‘Uttar Basti’: ‘Shatpushpa tail’ 3- 5 ml (3 days) For ‘Pratimarsh Nasya’ : ‘Shatpushpa tail’ 2 drops in each nostril twice daily for three consecutive cycle For Dhavan karma : Dashmool kwath Assessment criteria:- Assessment will be done on the basis of changes seen in the Subjective and Objective criteria. Subjective criteria:- • Abnormality in menstrual cycle like interval, duration, amount of bleeding, pain. • Other associated symptoms like stress, insomnia. Objective criteria:- • Conception • Tubal Patency • Ovulation • Endometrial thickness |