| CTRI Number |
CTRI/2026/02/103560 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Infertility WSR to Ovulatory Dysfunction |
|
Scientific Title of Study
|
AN OPEN LABELLED OBSERVATIONAL CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF VIRECHANOTTARA MUSTADIYAPANA BASTI FOLLOWED BY VISHNU TAILA UTTARABASTI IN VANDHYATVA W S R TO OVULATORY DYSFUNCTION |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaithra S T |
| Designation |
Panchakarma PG Scholar |
| Affiliation |
taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari |
| Address |
Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India Bellary KARNATAKA 583101 India |
| Phone |
7019847268 |
| Fax |
|
| Email |
chaitrast2020@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Doddabasayya kendadmath |
| Designation |
Associate professor department of panchakarma |
| Affiliation |
taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari |
| Address |
Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India Bellary KARNATAKA 583101 India |
| Phone |
9986916015 |
| Fax |
|
| Email |
drkendadamath@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Doddabasayya kendadmath |
| Designation |
Associate professor department of panchakarma |
| Affiliation |
taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari |
| Address |
Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India Bellary KARNATAKA 583101 India |
| Phone |
9986916015 |
| Fax |
|
| Email |
drkendadamath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Post Graduate studies in Panchakarma,
Taranath Government Ayurvedic Medical College And Hospital.
Ballari – 583101.
|
|
|
Primary Sponsor
|
| Name |
Pandit Taranath Government Ayurvedic Medical College And Hospital. Ballari |
| Address |
Pandit Taranath Government Ayurvedic Medical College And Hospital. Ballari |
| 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 Doddabasayya kendadmath |
Taranath Govt Ayurveda Medical College and Hospital Bellary. |
Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India
Department of PG studies in panchakarma , Taranath government ayurvedic medical college and hospital ,dr rajkumar road ,Ballari 583101 Karnataka , India Bellary KARNATAKA |
09986916015
drkendadamath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Taranath govt ayurveda medical college Ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)Married women of age between 21 to 45 year with anovulatory cycles.
2)Patients of anovulatory cycles with PCOD.
3)Patients of the Primary or Secondary infertililty.
4)Patient fit Virecana karma, Basti and Uttarabasti
|
|
| ExclusionCriteria |
| Details |
1) Known case of uterine anomalies , Fibroids and Malignant lesions of ovaries and uterus .
2) Patient with history of Tubercular endometritis, Pelvic inflammatory disease.
3) Systemic disorders like uncontrolled HTN, DM, Hypothyroidism, severe anaemia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Conception achieved |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective parameters improved |
3 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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="3" 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
|
Infertility is becoming major issue in today’s society due to the declining rate of fertility and fecundability.Infertility is defined as failure to conceive within one or more year of regular unprotected coitus1Currently infertility affects around 1 in 7 couples of reproductive age2, where ovulatory factor contribute 30-40%3 which often causing psychological disorders due to stress, junk food habits, sedentary lifestyles, anxiety which inturn leads to hormonal imbalance and alters ovulation.According to Susrutha, successful conception depends upon ritu,kshetra,ambu and beeja4. Beeja, most essential part among the four has been considered as antapushpa i.e. Ovum and in its absence Garbha can’t form inspite of all other factors. So, ovulatory dysfunction can be included under beejadushti. Virecana karma is one of the prime purifactory procedure, which will act on tridosha. Acharya Kashyapa indicated virecana in Agarba and garbakama5.The effect produced by virecana improve the quality of Beeja i.e. ovum and sperm. So, in this study snehapanawith Dhatryadi grita6 which is having vandyaharaguna has been taken followed by Virecanakarma with Haritakyadi churna7. Vata dosa is governing factor of whole reproductive physiology8. In this aspect basti is considered to be best treatment for vata. As Bastidravya spreads all over the body through strotas whichpacifice the doshicvitation and regularizes Agni and when given through the gudamarga it normalizes apanavata. Apana vata concerned with expulsion of sukra and artava.9Mustadi raja yapanabasti is Putrada and has Rasayana10 effect. Administration of drugs through Uttaramarga is known as Uttara Basti. It is administered after Niruha and it has shrestaguna. According to Acharya Caraka Uttarabasti will normalizes the functions of vatathereby helps in women for Garbha grahana.So here Uttarabasti given with Visnu taila11. In this study an attempt will be made to evaluate the effect of Virecana followed by Mustadiyapanabasti followed byUttarabasti with Vishnu tailaby means of clinical trial in streevandhyatwaw.s.r to ovulatory dysfunction . As there are no previous studies taken place in RGUHS and onlyfew studies carried out at other universities like Jamnagar but detailed information is not available to take for comparative or controlled group on this topic. Hence this observational study has been taken for clinical trial. So the study is entitled as – “AN OPEN LABELLED OBSERVATIONAL CLINICAL STUDY TO EVALUATE THE COMBINED EFFECT OF VIRECHANOTTARA MUSTADIYAPANA BASTI FOLLOWED BY VISHNU TAILA UTTARABASTI IN VANDHYATVA W.S.R TO OVULATORY DYSFUNCTION ”has been undertaken. |