| CTRI Number |
CTRI/2025/08/093530 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To see the effect of Prapaundarikadi Taila Pratimarsha Nasya, Shiroabhyanga and a combination of both in management of Akala Palitam (Premature graying of hair) |
|
Scientific Title of Study
|
An open label comparative triple arm clinical study to evaluate the efficacy of Prapaundarikadi Taila Pratimarsha Nasya, Shiroabhyanga and a combination of both in management of Akala Palitam (Premature graying of hair) |
| 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 Neha |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Opd no 2, PG Department of Swasthavritta and Yoga, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Sector 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
7011795429 |
| Fax |
|
| Email |
nehadalal1655@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Rani |
| Designation |
HOD & Professor |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Opd no 2, PG Department of Swasthavritta and Yoga, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Sector 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9466786108 |
| Fax |
|
| Email |
seemaranimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
Opd no 2, PG Department of Swasthavritta and Yoga, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Sector 8, Umri Road, Kurukshetra
HARYANA
136118
India |
| Phone |
7011795429 |
| Fax |
|
| Email |
nehadalal1655@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna Ayush University 136118 Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna Ayush University |
| Address |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna Ayush University Sector 8 Umri road Kurukshetra 136118 Haryana India |
| Type of Sponsor |
Other [Government Ayurvedic 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 Seema Rani |
Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana |
Opd no 2, PG Department of Swasthavritta and Yoga, Institute for Ayurved Studies and Research, Shri Krishna Ayush University, Sector 8, Umri Road, Kurukshetra
Kurukshetra
HARYANA |
09466786108
seemaranimd@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:L671||Variations in hair color. Ayurveda Condition: AKALAPALITAH/PALITAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Ch.chi. 26/276-277, Procedure details: 2 bindu (1ml) each nostril twice a day)
(1) Medicine Name: Prapaundarikadi Taila, Reference: A.H. 24/44-45, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 60 Days | | 2 | Comparator Arm | Procedure | - | Siro~aBya~ggaH, शिरोरऽभ्यंग | (Procedure Reference: A.H.U 24/44-45, Procedure details: 5 ml for 5 minutes once a day)
(1) Medicine Name: Prapaundrikadi Taila, Reference: A.H. 24/44-45, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 60 Days | | 3 | Comparator Arm | Procedure | - | pratimarSaH, प्रतिमर्श and Shiroabhyanga | (Procedure Reference: Ch. Chi. 26/276-277, A.H.U 24/44-45, Procedure details: 2 bindu (1ml) each nostril twice a day and 5 ml for 5 minutes once a day)
(1) Medicine Name: Prapaundrikadi Taila, Reference: A.H. 24/44-45, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. The patient between the age group of 20-30 year of both sexes.
2. Patient having feature of Akala Palitam as per Ayurvedic and modern literature (Premature graying of hair).
3. Consent obtained from respective patient.
4. Patient indicated for Pratimarsha Nasya Karma and Shiroabhyanga. |
|
| ExclusionCriteria |
| Details |
1. Patient of age below 20 years and above 30 years of either sex.
2. History of congenital or hereditary gray hair.
3. Scalp infections or dermatological conditions affecting the scalp or hair (e.g., psoriasis, eczema, severe dandruff).
4. Presence of any chronic systemic illness, such as (Hypothyroidism or hyperthyroidism vitiligo, Diabetes mellitus, Severe anemia, Autoimmune disorders).
5. Patient contraindicated for Pratimarsha Nasya Karma and Shiroabhyanga.
6. Use of hair dyes, chemical treatments, or hair coloring products in the past 3 months.
7. Addiction to smoking, alcohol, or other drugs which may influence hair pigmentation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the count of Graying severity score (GSS). |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Symptoms such as
1. Akala kesh vaivarnyata (Colour of hair)
2. Rooksha sphutitha (Dry splitted hair)
3. Snigdha sthool (Oiliness)
4. Daha (Burning sensation of scalp. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/09/2025 |
| 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
|
In this trial we are selecting patients of Akala Palitam (Premature graying of hair) and dividing them into three groups (20 patients in each group). In the 1st group we will do intervention with Prapaundarikadi Taila Pratimarsha Nasya. In the 2nd group we will do intervention with Prapaundarikadi Taila Shiroabhyanga and In the 3rd group we will do intervention with Prapaundarikadi Taila Pratimarsha Nasya along with Shiroabhyanga (a combination of both). A comparative study is to be done on the basis of subjective parameters such as Akala kesh vaivarnyata (colour of hair), Rooksha sphutitha (dry, split hair), Snigdha sthool (oiliness), Daha (burning sensation of scalp) and the objective parameter Graying Severity Score. Statistical analysis will reveal significant variations between Group A, Group B and Group C. These findings help to identify the unique strengths and limitations of each group, offering valuable insights for targeted strategies and future research. |