| CTRI Number |
CTRI/2025/12/098413 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on TULHA tablets in participants with Delayed Periods |
|
Scientific Title of Study
|
Clinical study to evaluate efficacy and safety of TULHA tablets in participants suffering from Delayed Periods (Oligomenorrhea)- An Open Label, Prospective, Interventional, Multi-center, Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TULHA/GYNOVEDA/OLIGOMEN/2025/1, Version 1.0, 17th Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Deore |
| Designation |
Ayurveda Consultant Physician |
| Affiliation |
Shree Sai Ayurvedic Panchakarma Rugnalaya |
| Address |
Shree Sai Ayurvedic Panchakarma Rugnalaya
Department of Medicine, OPD no.1, 2nd Floor,
Kohinoor Arcade, Bus Stop, Sector No. 24, Pradhikaran,
Nigadi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822634478 |
| Fax |
|
| Email |
dravinashdeore2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd, A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd, A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA
400064
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Gynoveda Femtech Pvt. Ltd
Access work Level-9, Eureka Tower,
A-Wing Mindspace-IT Park, Chincholi Bunder
Malad West, Mumbai,
Maharashtra 400064
|
|
|
Primary Sponsor
|
| Name |
Gynoveda Femtech Pvt. Ltd |
| Address |
Access work Level-9, Eureka Tower, A-Wing Mindspace-IT Park, Chincholi Bunder
Malad West, Mumbai,
Maharashtra 400064
|
| Type of Sponsor |
Other [Healthcare Industy] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archana Jadhav |
Ayurved Seva Sangh, Ayurved Mahavidyala |
Department of Prasuti Tantra Department, OPD No. 5, Ground Floor, Ganeshwadi,. Nashik -422003
Nashik
MAHARASHTRA |
7775058616
archujadhav88@gmail.com |
| Dr Prathima |
SDM College of Ayurveda and Hospital |
Dept. Prasuti Tantra & Stree Roga, OPD No. 21, Ground Floor, Bangalore - Mangalore Hwy, Thanniruhalla, Hassan-573201
Hassan
KARNATAKA |
9611990497
drprathima@sdmcahhassan.org |
| Dr Avinash Deore |
Shree Sai Ayurvedic Panchakarma Rugnalaya |
Department of Medicine, OPD no.1, 2nd Floor, Kohinoor Arcade, Bus Stop, Sector No. 24, Pradhikaran, Nigadi, Pune -411044
Pune
MAHARASHTRA |
9822634478
dravinashdeore2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurveda Seva Sangh, Ayurveda Mahavidyalaya, Nashik |
Submittted/Under Review |
| Institutional Ethics Committee SDM College of Ayurveda & Hospital, Hassan |
Submittted/Under Review |
| Kusum Independent Ethics Committee, Hadapsar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: TULHA Tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Samudga, Duration: 120 Days, anupAna/sahapAna: No, Additional Information: 2 tablets of TULHA two times daily after meals with water for 120 days | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female (married and unmarried) patients diagnosed with delayed periods (35 to 90 days) since 2 cycles
2. Female with natural periods without OC or hormonal pills
3. Subjects with serum AMH 1 to 4 ng per ml
4. Subjects with normal Serum FSH level
5. Subjects willing to provide written informed consent and ready to comply with the study protocol.
Note: Subjects with Intramural and subserosal fibroids less than 2 cm and ovarian cysts less than 2 cm in size will be included
|
|
| ExclusionCriteria |
| Details |
1. Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids greater than 2 cm, endometriosis, chocolate cysts, cervical erosion and PCOD (as diagnosed by USG).
2. Subjects with heavy and extended (10 days) bleeding
3. Subjects with submucosal fibroids
4. Subjects having hyperprolactinemia.
5. Subjects having known systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, hirsutism, Addison disease and or Cushing disease.
6. Subjects with known HIV, cancer, hepatitis B and C.
7. Known cases of autoimmune and chronic debilitating disease
8. Subjects on anti-depressant medications
9. Pregnant and lactating women.
10. Use of corticosteroids or hormones or hormonal drugs within last 1 month from screening visit.
11. Use of any other investigational drug within 1 month prior to screening visit.
12. Known hypersensitivity to ingredients used in study drug.
13. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of subjects achieving regular frequency of menstrual cycle |
Baseline visit, Day 30, Day 60, Day 90 and Day 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in number of bleeding days, amount of menstrual bleeding
2. Number of subjects achieving ovulation during the study period
3. Change in symptoms associated with delayed periods
4. Change in weight and BMI
5. Change in skin glow
6. Assessment of spontaneous pregnancy
7. Global assessment for overall change by subject and investigator
8. Tolerability of study medications as assessed by participants and investigator
9. Safety evaluation by assessing adverse events, clinical symptoms, signs, vitals and laboratory tests
|
Baseline visit, Day 30, Day 60, Day 90 and Day 120 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
12/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is an open label, prospective, interventional, multi-center, clinical
study to evaluate efficacy and safety of TULHA tablets in participants
suffering from Delayed Periods (Oligomenorrhea). The study will be conducted at
10 to 12 centers in India. Subjects will be asked to take 2 tablets of TULHA
two times daily after meals with water for 120 days. Primary objective of the
study will be to assess number of subjects achieving regular frequency of
menstrual cycle. The secondary objectives of the study will be to assess changes
in number of bleeding days, amount of menstrual bleeding, number of subjects
achieving ovulation during the study period, change in symptoms associated with
delayed periods, change in weight and BMI, change in skin glow, spontaneous
pregnancy, global assessment for overall change by subject and investigator, tolerability
of study medications as assessed by participants and investigator, safety
evaluation by assessing adverse events, clinical symptoms, signs, vitals and
laboratory tests on Baseline visit, Day 30, Day 60, Day 90 and Day 120 |