| CTRI Number |
CTRI/2025/01/079059 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| 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
|
To see the effect of an ayurvedic medicine in the management of infertility due to anovulation |
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical Study to Evaluate the Efficacy of Kashmaryadi Ghrita Uttarbasti and Phala Ghrita Uttarbasti in the management of Stree Vandhyatva wsr Anovulatory Factor |
| 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 ALVIN |
| Designation |
MS SCHOLAR PRASUTI TANTRA EVAM STREE ROGA |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
OPD NO 15 DEPARTMENT OF PRASUTI TANTRA EVAM STREE
ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH
UMRI ROAD SECTOR-8 KURUKSHETRA HARYANA
136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9671551504 |
| Fax |
|
| Email |
alvinbawalia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNITI TANWAR |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF PRASUTI TANTRA EVAM STREE ROGA |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
OPD NO 15 DEPARTMENT OF PRASUTI TANTRA EVAM STREE
ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH
UMRI ROAD SECTOR-8 KURUKSHETRA HARYANA
136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9996311778 |
| Fax |
|
| Email |
drsunititanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ALVIN |
| Designation |
MS SCHOLAR PRASUTI TANTRA EVAM STREE ROGA |
| Affiliation |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
OPD NO 15 DEPARTMENT OF PRASUTI TANTRA EVAM STREE
ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH
UMRI ROAD SECTOR-8 KURUKSHETRA HARYANA
136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9671551504 |
| Fax |
|
| Email |
alvinbawalia@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR AYURVED STUDIES AND RESEARCH SEC 8 UMRI ROAD KURUKSHETRA HARYANA
136118
INDIA
HARYA |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
| Address |
UMRI ROAD SECTOR-8 KURUKSHETRA
HARYANA
136118
INDIA |
| 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 ALVIN |
INSTITUTE FOR AYURVED STUDIES AND RESEARCH |
OPD NO 15 DEPARTMENT OF PRASUTI TANTRA EVAM STREE
ROGA INSTITUTE FOR AYURVED STUDIES AND RESEARCH
UMRI ROAD SECTOR-8 KURUKSHETRA
HARYANA
136118
INDIA
Kurukshetra
HARYANA |
9671551504
alvinbawalia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI KRISHNA AYUSH UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KASHMARYADI GHRITA, Reference: CHARAKA CHIKITSA STHANA ADHYAYA 30 YONIVYAPATACHIKITSA ADHYAYA SHLOK 52-53, Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: UTTARBASTI FOR 3 DAYS AFTER CESSATION OF MENSES FOR 3 CONSECUTIVE CYCLES | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: PHALA GHRITA , Reference: SHARANGDHAR SAMHITA MADHYAM KHAND 9/80-87, Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: -UTTARBASTI FOR 3 DAYS AFTER CESSATION OF MENSES FOR 3 CONSECUTIVE CYCLES |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married female of age from 21 to 40 years
Patient having anovulation with or without PCOD
Primary and secondary both types of infertility due to ovulatory factor defect
Patients who will agree for consent necessary investigation and agreed for regular
follow up
Patient who will fulfill diagnostic criteria
Patient willing to participate in trial |
|
| ExclusionCriteria |
| Details |
Female of age group less than 21years and more than 40 years
Patient with uncontrolled HTN TB DM and any other systemic diseases
Patients having benign and malignant tumors of uterus and ovaries
Pregnancies are excluded
Patients having bleeding disorders
Patients having acute and chronic pelvic inflammatory disease STD Chromosomal
abnormalities
Patients having congenital anomalies of genital organs
Patient having adenomyosis tubercular endometritis endometriosis tubal blockage
fibroid uterus
Cause of infertility in patient is other than anovulatory factor |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trial drugs will help in ovulation induction of patient |
Follow up for the subjective parameters will be done after every cycle on 5th day for 3 consecutive months
Follow up for objective parameters will be done after 3 months(13 weeks) by Ultrasonography |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Trial drugs will help in curing menstrual abnormalities associated with
anovulation like irregular & scanty /excessive menstruation |
Follow up for the subjective parameters will be done after every cycle on 5th day for 3 consecutive months
Follow up for objective parameters will be done after 13 WEEKS by Ultrasonography |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
God has bestowed women with the ability to carry forward the lineage.Acharya Charaka has specified that only women holds the power to conceive.Due to this ability a women has been given a status of high respect in the society. The importance of Santan(child) has been explained in Charaka Samhita that the love,strength ,happiness,livelihood,expansion of family ,attainment of fame,prestige in world ,future ,happy life ,satisfaction are all under the influence of children.But unfortunately many couples are devoid of this beautiful experience due to infertility. Infertility is defined as a failure to conceive within one or more years of regular unprotected intercourse.It can be classified into primary and secondary .Out of many causes ,most common cause of female infertility is anovulation i.e. 30-40% of all .This can be anovulation or severe oligo ovulation .In oligo ovulation ,ovulation does occur but in irregular frequency which decreases the chances of pregnancy . In classical texts of Ayurveda foetus is termed as “Garbha†when shukra (semen ) and aartava (ovum) meet with atma inside the kukshi ,4 vital factors are essential for Garbh(attainment of foetus ) . These are Ritu(fertile period) Kshetra (female reproductive organ) Ambu (proper nutrients and fluid ) Beeja(ovum and sperm ) In female body Beeja denotes ovum .Formation of Beeja takes place in ovary . Yoni is place of Vata and Vata plays vital role in beejotsarga and folliculogenesis by karma and swabhava .Release of egg from ovary is termed as Beejotsarga .Beeja plays crucial role in female reproductive process and in absence of this Garbha cannot be formed inspite of proper Ritu ,Kshetra and Ambu . So anovulation can be correlated with Beeja Dushti and its indeed an important factor causing infertility as per Ayurveda and modern sciences.Therefore to find an effective way of treatment for this , we will be using Kashmaryadi Ghrita Uttarbasti and Phala Ghrita Uttarbasti in the management of Vandhyatva w.s.r. to Anovulatory Factor |